Longevity Industry Jobs

Regeneron's Bioanalytical Sciences group, located in Tarrytown, NY, is looking for a Scientist. In this role you will drive bioanalysis for clinical studies within Bioanalytical Sciences (BAS) and act as the liaison between BAS, clinical study teams, and external partners (i.e., Contract Research Organizations [CROs]), to effectively manage pharmacokinetics (PK), immunogenicity, and biomarker deliverables.

A Typical Day In The Role Might Look Like

• Responsible for managing bioanalytical activities and supporting the Bioanalytical Principal Investigator for clinical studies.
• Act as a liaison between Bioanalytical Sciences (BAS), external partners (i.e., CROs), and clinical development team; work closely with groups within BAS, Clinical Pharmacology group, clinical study teams, and other working groups to establish bioanalytical deliverables and timelines for multiple projects.
• Review sample analysis documentation and clinical sample analysis reports. Supports regulatory submissions and responses to regulatory inquiries.
• Review clinical study-related documents including expanded synopses, protocols, and amendments.
• Review SOPs, publications, and guidelines to ensure the conduct of bioanalysis is aligned with industry practice and/or regulatory expectations.
• Participate in internal and external project teams. Prepare and present scientific data at internal and external meetings.

This Role Might Be For You If You

• You are a self-motivated, energetic individual
• You enjoy working in a fast-paced, cross-functional setting
• You thrive in a team-based, collaborative environment
• You possess strong communication skills, demonstrate effective project management abilities, and have excellent interpersonal skills.

This role requires a M.S. degree with a minimum of four years of experience in a role related to bioanalytical sciences or a similar field, or a B.S degree with a minimum of seven years of relevant experience. Experience with bioanalytical techniques, e.g., ELISA, ECL, MSD, LC-MS/MS, PCR, flow cytometry, or immunogenicity assays is preferred. Experience with writing/reviewing scientific documents, reports, or contributing to regulatory submissions a plus.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

The Associate Medical Director is a qualified physician-scientist with experience in the pharmaceutical/biotechnology sector, or academic clinical setting. The Associate Medical Director works with supervisor and other members of the cross-functional study team to author/contribute to early clinical development protocols and facilitate execution of study activities and data summarization. Early Clinical Development and Experimental Sciences (ECDES) is uniquely poised to shepherd our internal discovery portfolio and external collaboration programs through clinical proof of concept (POC). In close partnership with Regeneron Labs, ECDES uses human clinical studies to inform upon biology and identify which candidates have the most promise as new medicines. ECDES has core functional capabilities to enable the sustainable delivery of the early development strategy including Clinical Science, Precision Medicine & Operations, and Clinical Imaging. Together with Regeneron’s technology platforms, ECDES effectively integrates genetic and molecular characterization of human disease biology to advance our clinical studies.

As an Associate Medical Director, a typical day may include the following:

• Facilitates/leads the cross-functional study team on the following activities, including but not limited to:
• Designs POC-enabling human studies, First-In-Human (FIH) studies, POC (clinical and/or pharmacologic) studies as per clinical strategy.
• Responsible for the relevance and accuracy of medical science underpinning of clinical study based on thorough scientific review and consultation with internal and external experts
• Reviews, edits and finalizes clinical trial plans
• Organizes and conducts consultations with global opinion leaders
• Reviews and finalizes the medical and scientific portions of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments.
• Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions
• Responsible for oversight of cross-functional study team and provides medical guidance to the clinical study teams
• Accountable, with input from Clinical Trial Management and Biostatistics and Data Management for timely clinical trial execution and quality of deliverables
• Leads and supervises the Clinical Team to produce high quality program deliverables on schedule

This Role May Be For You If

• Effective communications (verbal & written) and presentation skills are essential.
• Must be able to work productively in a fast-paced collaborative environment.
• Demonstrated critical thinking skills and sound decision-making

To be considered for this role, you must have an M.D. Degree (M.D./Ph.D. Degree preferred) Board Certification/Eligibility in a relevant therapeutic area preferred, along with relevant industry experience. A minium of 2-3yr (Associate Director), 4-8yr (Director) prior industry experience or practice experience, preferably in a research/academic setting. Experience in analysis of clinical and basic research information from a wide range of topics.

#MDJOBS, #MDJOBSCD #GDECDJobs LMC

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

The Protein Expression Sciences - AAV team is seeking an independent and highly motivated Sr Scientist to support the stable cell line development of viral vector technology. You will be conducting research activities around the design, characterization, and validation of engineered adeno-associated viruses (AAV) components stable integration, to build a novel platform to Regeneron’s gene therapy technology.

As a Sr Scientist, a Typical Day Might Include

• Designing gene expression vectors.
• Performing molecular biology techniques (Cloning, Western blotting, DNA/RNA extractions, PCR, RT-PCR, quantitative PCR, etc.).
• Creating and validating stable integration cell lines.
• Developing cell-based assays to analyze AAV vectors efficacy.
• Working collaboratively with team members, and with collaborators in various therapeutic focus areas and core facilities across research and discovery.
• Participating in team meetings and preparing regular presentations.

This Role May Be For You If You

• Enjoy working in an innovation driven, highly collaborative and fast paced environment.
• Can effectively balance multiple projects independently with minimal supervision.
• Have relevant experience in molecular biology techniques, mammalian cell culture, development and employment of cell-based assays.
• Have scientific rigor and pay attention to details.

To be considered for this role, you must have a MS degree with 8 years, BS with 10 years of relevant experience or PhD in molecular biology, biochemistry, biotechnology, virology or related field.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

This is a hybrid role on-site 3 days per week in Basking Ridge, NJ or Tarrytown, NY and 2 days from home. Fully remote work is not an option for this position.

The Director will be responsible for leading pharmacoepidemiologic projects and activities in the area of oncology, with direction in support of marketed and/or development compounds, commensurate with experience/skill, in accordance with global regulations and Regeneron SOPs and working practices and serve as in-house resource on pharmacoepidemiology to other departments. The candidate should be knowledgeable in the latest epidemiologic methods and resources to be able to be adaptable within cross functional teams and to guide decision making where needed.

A Typical Day Includes

• Responsibility for implementation of pharmacoepidemiology strategy, generation of real-world evidence (RWE), and conduct of regulatory-agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements
• Actively contributing to other pharmacoepidemiologic activities as a subject matter authority for assigned marketed/development compound(s) or TAs, including but not limited to: (Development) Risk Management Plans, Benefit-Risk analyses, post-approval safety studies that may not be required by a regulatory authority, signal management, responses to regulatory agency queries, regulatory filings, safety surveillance, and others
• Working closely with Global Patient Safety Leads, Safety Scientists, Regulatory Affairs, Clinical Scientists and other interested parties, provide timely epidemiological and risk management support to project and product teams including design, implementation, and analysis of epidemiological studies, review of study proposals from internal and external sources, reviews of the literature, and database activities such as exploring external electronic, patient-level database(s) (administrative claims/EMR/surveys/registries etc.) to evaluate safety/benefit questions, disease natural history, and other appropriate epidemiologic data in support of clinical development and regulatory filings
• Representing Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed
• Handling and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)
• Actively participating in process improvement activities within the department and Global Patient Safety as needed

This Job May Be For You If You

• Function as a subject matter authority on pharmacoepidemiology for assigned compounds/projects with proven history of working on diverse and complex matters
• Have op-to-date knowledge of US and international regulatory guidances (e.g., pharmacovigilance, RWE, good epidemiology practices) and ability to apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle
• Have experience using automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities Significant experience working with cross-functional teams and external vendors
• Excellent written and verbal communication skills
• Have a consistent record of interpersonal, leadership, and project management skills

To be considered you must have a PhD in Epidemiology with 5+ years of related pharmaceutical industry experience.

#GDGPSJobs

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Regeneron is looking for an energetic and talented individual to join and play a key role in our Financial Planning & Analysis Team. As a key member of Corporate Finance team, responsibilities of Associate Manager – FP&A will include preparing Board presentations, monthly finance package, earnings support package, quarterly financial guidance package by successfully partnering with functional finance teams and other finance functions such as accounting, tax, treasury. The ideal candidate is detailed oriented and analytical with the ability to see the bigger picture.

Key Responsibilities

• Prepare Board presentations, annual budget, monthly finance package, quarterly earnings support package, quarterly financial guidance package
• Update and improve the existing excel models that are leveraged for preparing corporate finance deliverables and for performing financial analysis
• Forecast certain key inputs that include people expense, stock based compensation expense, royalty income, amortization resulting from transactions, fully diluted share count, free cash flow
• Partner with key functional finance team members to gather forecast vs forecast, actual vs forecast variances
• Partner with accounting team to update the models to correctly reflect the quarterly actuals and to align on quarterly Non-GAAP adjustments, accounting treatments of business transactions, collaborations
• Partner with tax team to prepare quarterly legal entity financials that are used for forecasting effective tax rate
• Partner with treasury team to prepare cash flow statements and to forecast activities related to stock options, restricted stocks and share buybacks

Desired Skills

• 4+ years of progressive professional experience demonstrating increasing responsibility, scope
• Experience in building integrated financial statements that can leveraged for budgeting
• Strong analytical and financial modeling skills and experience with financial systems, preferably Hyperion
• Excellent communication, presentation, and organizational skills
• Demonstrated ability to thrive in a dynamic and fast-paced environment
• Bachelor’s degree in finance, accounting or related field is required; MBA/CPA/CFA is desirable

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

We are currently looking to fill a Sr Facilities Compliance Specialist (Technical Writing) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department.

*This is an onsite position located in Rensselaer, NY*

As a Sr Facilities Compliance Specialist, a typical day might include the following:

• Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance
• Manage and participate in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements
• Facilitate reviews and revisions of Facilities Department related Standard Operating Procedures, Work Instructions, Risk Assessments, and OJT Task Evaluations for each group within the Department
• Manage and provides support, information, and assistance to individuals and groups with the initiation, review, submission, and follow-up of documents such as Change Controls and Corrective and Preventive Action plans
• Participates in, and obtain results of, all Facilities Department quality and regulatory audits.

This Role Might Be For You If

• Have extensive technical writing experience in a manufacturing environment, pharmaceutical industry preferred
• You can prioritize multiple assignments and changing priorities in a fast-paced environment
• You have an understanding of equipment and terminology used in a manufacturing operation
• You are organized and have an attention to detail
• You excel in a collaborative, cross functional environment

Role

To be considered for this role you must hold a Bachelor’s degree and the following minimum amounts of relevant experience for each level

• Associate Specialist – 0-2+ years
• Specialist - 2+ years
• Sr Specialist – 5+ years

May substitute relevant experience in lieu of educational requirements. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Regeneron's Preclinical Manufacturing & Process Development Group (PMPD) is seeking a Process Development Associate II as a full time position to work in the Purification Development group. In this role, you will be responsible for the purification of various pre-clinical biological molecules to provide reagents and therapeutics for Regeneron’s research and discovery groups. The ideal candidate will be hardworking, efficient, flexible, and able to perform key responsibilities in a fast-paced, team environment.

A Typical Day In The Role Might Look Like

• Purification of a diverse array of proteins to support many of Regeneron’s research and discovery groups
• Process development for clinical processes
• Development of technology and automation to increase process throughput and efficiency of preclinical manufacturing
• Documentation of experiments, results, and findings in an electronic laboratory notebook; presentation of work at group and department meetings.
• Maintenance of instruments and troubleshooting of instrumental/experimental problems
• Collaboration with peers to complete core deliverables while exhibiting independence in experimental execution and trouble-shooting

This Role Might Be For You If You

• Enjoy a fast paced pilot scale laboratory setting where sound science and team work are priorities.
• Contribute to lab equipment maintenance and safety to help create a safe, effective, and efficient working environment.
• Anticipate and recognize potential problems with laboratory supplies / equipment and act to prevent and tackle problems.
• Keep up with SOP training and/or compliance responsibilities.
• Are scientifically curious, enthusiastic, and proactively ask questions to learn or seek clarification.

The role requires a Bachelor’s and/or Master’s degree in either Chemical Engineering, Biochemical Engineering, or Biochemistry, and 0 - 5+ years’ experience in the biotech or pharmaceutical industry. A strong fundamental understanding of various protein purification techniques a plus. Experience with Downstream Development and with equipment like Akta Explorers/Avants/Pilots, chromatography columns, tangential flow filters, depth filters, HPLCs, and UPLCs as well as software such as Empower, Unicorn, JMP, and LIMS is a plus. Job will periodically require short duration physical exertions, including light-medium weight lifting.

#pmpd

Intro To PMPD Video

https://www.youtube.com/watchv=pAboGKlI1zw&list=PL_7lj13Lp4fH4OssUue8J5bby6muZsaR4&index=5

Intro To PMPD Purification Video

https://www.youtube.com/watchv=aZ82TmphmfA&list=PL_7lj13Lp4fH4OssUue8J5bby6muZsaR4&index=6

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

The Immunology and Inflammation group is seeking an independent and highly motivated associate scientist to support the development of therapeutics for autoimmune disease. This role involves joining a highly collaborative team working in autoimmunity, immune cell biology, and tissue immunity. The applicant should be excited to engage in cutting edge immunological research as part of our discovery efforts and to contribute to human health at every stage of drug discovery and development. You will have the opportunity to support a broad pipeline in all of immunity and inflammatory diseases by executing in vivo experiments as well as in vitro assays.

As a scientist, your typical day might include the following:

• Designing, planning, and/or performing in vivo studies using moue lung inflammation models and allorejection models.
• Processing of organs for immune cell isolation and analysis.
• Maintaining, expanding, and/or modulating cells and evaluating using in vitro assays.
• Analysis of data using biological and statistical software such as FlowJo, Excel, Prism.
• Close collaborative interactions with teams across the organization.
• Documentation of experimental procedures and results.

This Role May Be For You If You

• Prefer working in an innovative and team-driven environment.
• Possess excellent organizational skills.
• Communicate openly and frequently with manager and team members.
• Exhibit strong communication and critical thinking skills.
• Enjoy creativity, independent thinking, and finding solutions to seemingly “impossible” problems.
• Seek an opportunity to constantly grow and learn about new areas through collaborative projects across multiple teams.

Training in the proper handling and care of mice and the collection and processing of blood and tissue samples is strongly preferred. Experience in techniques including tissue culture (primary cells), cell-based assays, and flow cytometry is highly desirable. Expertise in in vivo mouse respiratory modeling and surgery technique are highly preferred. You will have the opportunity to engage with multiple projects in a fast-paced and data-driven environment with both basic research and pipeline implications.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

We are seeking a Physician Scientist to join our Neuroscience and Ophthalmology Therapeutic Area Genetics (TAG) team. You will be a subject matter authority in the translation of human genetic evidence into concrete insights in neurological, psychiatric, ophthalmological, and aging-related diseases. You will work closely with other teams in the Regeneron Genetics Center and Regeneron at large and be primarily responsible for designing, contributing to the execution of, and interpreting large and complex human genetic studies in the therapeutic areas. We hope you are excited by the opportunity to play a role in the development and implementation of innovative translational sciences and identify new therapeutic targets through genetic approaches.

As a Physician Scientist in Neurology/Ophthalmology, a typical day might include the following:

• Applying human genetics to target discovery, selecting indications for drug programs, and identifying subgroups of patients who are more likely to respond to treatment through genetic analyses.
• Working with a multidisciplinary genetics team consisting of human genetics scientists, bioinformaticians, statistical geneticists, and other team members to design, implement, and interpret genetics studies in ophthalmology.
• Working in close collaboration with other TAG team members and forming a strong partnership with Genome Informatics, Analytical Genomics, Clinical Informatics, and other RGC teams to deliver on complex, top-quality scientific endeavors in these Therapeutic Areas.
• Generating, summarizing, and presenting results in internal and external meetings to a variety of audiences.
• Leading or contributing to the writing of scientific reports and publications.
• Representing the TAG team in cross-functional initiatives within RGC and Regeneron.
• Collaborating with external industry and academic partners in scientific consortia.

This Job May Be For You If

• You have demonstrated ability to design and lead human genetics studies delivering medically relevant findings in a team-based environment.
• You use medical knowledge to define relevant phenotypes for genetic association studies and to formulate innovative and important research questions. You have familiarity with clinical genetics concepts and various genetic models of disease.
• You have experience leading complex human genetics research endeavors, have knowledge of different study designs and analyses including GWAS, exome, or genome sequencing in cohort, case-control, or family-based studies, and have the ability to integrate different data resources to translate initial findings.
• You have an interest in understanding the genetic basis and causes of Neurological, Psychiatric, Ophthalmological, and Aging-related diseases and translating this knowledge into therapeutic insights. An outstanding candidate will have previous experience with phenotypes related to these diseases.
• You thrive working in a highly interactive environment with a diverse team of colleagues.
• You have outstanding communication skills and an ability to summarize and present the results of human genetic studies to a variety of audiences.

To be considered for this role, you must have an MD or MD/Ph.D. with a strong background in and knowledge of human genetics or genetic epidemiology. An MD/Ph.D. training and experience in translational human genetics, genetic epidemiology (or related fields), and strong quantitative skills. Familiarity with the applications of statistical genetics to gain medically insights including polygenic risk scores, quantitative traits analyses, and Mendelian randomization, and familiarity with command-line interface, programming languages, and statistical software (eg. Python, R) is preferred. Experience with the use of genetics in combination with other “omics” technologies (eg. epigenetics, proteomics, RNA-seq).

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

As a member of the Accounting Operations team, you will be responsible for assisting day-to-day operations and continuous improvement initiatives for the Accounting department. Your main tasks will include gathering data, performing analysis, and supporting projects and initiatives as needed.

A Typical Day Might Include The Following

• Perform ad hoc requests related to reporting and data analysis to assist other team members, management, and audit requests.
• Support the analysis and implementation of accounting operation functions relating to new technology projects throughout the organization
• Prepare documentation and Standard Operating Procedures (SOPs) for processes, enhancements and projects as needed
• Responsible for preparation of various schedules impacting the month-end close and reporting
• Assist team with the execution of test scripts for various projects
• Demonstrating knowledge of technical accounting standards under US GAAP, and its application to tasks at hand
• Participating in process improvement initiatives
• Demonstrating excellent verbal and written communication skills, including effective presentation skills
• High proficiency with Microsoft applications is required

This Role Might Be For You If

• You have worked in an accounting function for 3 - 5 years and/or hold a B.Sc. in accounting
• You are proactive and analytical problem solver with the ability to think outside of the box
• You have the willingness to learn new processes and technologies and can work in a collaborative and fast paced environment
• You can communicate effectively with colleagues and peers both verbally and non-verbally
• You are coachable, committed to change, and open to embrace new ideas and perspectives
• You are dependable, have strong organizational abilities, pay attention to details, and most importantly enjoy your work and have fun while doing it

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

Job Duties

A typical day might include the following:

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Job Requirements

• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
• Ability to work with a safety system database for purposes of medical case review and simple querie
• Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
• Ability to effectively communicate (verbal and written) safety findings
• Provide a background that includes: Master's, PhD, or PharmD
• Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

The Therapeutic Proteins Bioassay Group seeks a highly motivated and passionate Principal Scientist to join our team. In this role, you will focus on developing cell-based assays and high throughput screening methods to identify antibodies and TCRs to support the development of Treg cell therapies for autoimmune diseases.

A Typical Day In The Role Might Look Like

• Develop, optimize, and complete high throughput cell-based assays (viability/cytotoxicity, luciferase reporter, cytokine release, flow cytometry, imaging,)
• Isolate, phenotype, and expand human Treg cells
• Develop in vitro Treg bioassays
• Cell line engineering (overexpression via Lentiviral transduction/CRISPR mediated KO/KI)
• Lead, guide, and work with other Scientists to support multi-functional teams
• Communicate/coordinate activities, prepare and present data in cross-functional meetings
• Stay ahead of technological/scientific developments

This Role Might Be For You If You Have

• Passion for cell-based assay development and drug discovery
• Strong background in immunology
• Teamwork and problem solving in a fast-paced environment

This role requires a PhD in Immunology or related field and 4-6, an MS +with 8-10+or a BS with 12+ years relevant experience. The ideal candidate should have experience developing, optimizing, and troubleshooting immune cell-based assays and a background in regulatory T-cell biology. Experience culturing Treg cells preferred.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

We are currently looking to fill a Principal External Manufacturing Specialist position. oversees all aspects of external manufacturing contract manufacturing operations (filling, assembly, packaging) including day-to-day operations, ensuring timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance. Additionally, the Specialist provides guidance to other specialists as well as consults with management on all contract manufacturing operations and GMP compliance issues.

As a Principal External Manufacturing Specialist, a typical day might include the following:

• Serves as a Regeneron operational contact for contract manufacturing and/or business partner sites concerning day-to-day activities.
• Coordinates external manufacturing activities at contract and/or business partner sites, including but not limited to: scheduling of all batches, supply of materials, providing direction on shipment of bulk or finished product, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertise.
• Coordinates multiple external manufacturing activities at multiple sites, as required.
• Coordinates DS and FDS manufacturing at CMO as dictated by project.
• Liaises between various departments within Regeneron including, but not limited to Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, Legal, Regulatory, Strategic Sourcing and contract manufacturers or business partners.
• Leads sub-teams in continuous process improvements, system/equipment implementation and/or strategy development.
• Leads or supports all investigations which concern external manufacturing and associated shipping operations.
• Ensures product integrity and company reputation monitoring of cGMP compliance at external manufacturing contract manufacturers and business partners.
• Performs reviews of pre-production master batch records and completed batch records.
• Authors documents and procedures.
• Supports audit operations, both internal and external.
• Analyzes data for trends and potential issues.
• Travels 25% (target) or more (domestic and international), as required.

This Role May Be For You If You

• Knowledge of external manufacturing from formulation through the final package.
• Knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Proficient in Excel, PowerPoint, Visio, Word, Oracle etc. in addition to experience working within shared work environments.
• Strong interpersonal, written and oral communication skills.
• Exhibits confidence, has a high emotional IQ, and has strong interpersonal, written and oral communication skills for providing team updates.
• Ability to impart understanding of provided instructions, develop instructions and sets and works towards goals with minimal supervision.
• Exhibits a degree of ingenuity, creativity and resourcefulness in evolving and ambiguous environments.
• Shows resiliency and flexibility in the face of challenges and adversarial situations.
• Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.

To be considered you must have the following education and requirements.

• Requires BS/BA in a scientific field and 8 years of related experience in cGMP manufacturing operations (clinical and/or commercial external manufacturing), including experience collaborating with CMOs/CROs, or equivalent combination of education and experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

We are looking for an Associate Director, within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and on-going clinical programs primarily in the CV/Metabolism area

A day in the life an Associate Director may look like:

• Develop and maintain comprehensive clinical pharmacology strategic development plans for assigned development programs.
• Provide clinical pharmacology subject matter expertise to the Clinical Study Team/ Development Team.
• Participate in the drafting and finalization of clinical study protocols and study analysis plans (SAP).
• Conduct and/or supervise pharmacokinetic / pharmacodynamic analyses.
• Draft, finalize, and/or review clinical pharmacology study reports and publications. Work with the Medical Writing Team to incorporate PK/PD sections into clinical study reports.
• Work closely with Regulatory to provide clinical pharmacology support of regulatory documents, communications and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings).
• Collaborate with Quantitative Pharmacology colleagues to develop and deliver agreed quantitative strategies to support assigned development plans.
• Assist the Pre-clinical PK/PD Team as needed.

This may be the right role for you if you:

• Want the ability to make a significant impact on the organization and external groups and can influence and effect change.
• Enjoy making contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
• Want to work in cross-functional teams with forward-thinking, passionate, driven teammates

In Order to be considered qualified for this role you must have:

A PhD, Biology, Pharmacology, Engineering, Pharmacy (Pharm.D.), Medicine (MD) and at least 5 years of relevant Clinical Pharmacology experience. CV/Metabolic experience is strongly preferred, but not required.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

The Diagnostic Strategy Lead (CDxSL) within the Early Clinical Research and Experimental Medicine group will lead companion and complementary diagnostic development for assigned early and late development programs across multiple therapeutic areas including Immunology and Inflammation, Ophthalmology, Cardiovascular and Metabolic Disease and General Medicine. We are seeking a candidate to guide the development of strategies for patient selection/stratification and subsequently lead the implementation/execution of diagnostic assays (including assay development, analytical validation, implementation in clinical trials, global health authority submission strategy etc) in collaboration with internal and external partners/IVD manufacturers and central testing laboratories. Experience in supporting gene therapy programs using AAV vectors is considered of particular interest for this role.

As an Associate Director in Precision Medicine, a typical day may include the following:

• Identify innovative diagnostic strategies and be able to propose projects from idea to implementation taking into consideration all of the relevant inputs to ensure program success
• Design and author clinical trial protocol language to support the selection of patients and ultimately clinical claims for diagnostic tests, oversee operational aspects of CDx clinical trial implementation, manage timelines with internal and external partners
• Work in collaboration with CDx regulatory/commercial team from program inception to global health authority marketing approval
• Be viewed as a subject matter expert in companion and complementary diagnostic development and able to effectively communicate with clinical study teams on program direction
• Help define CDx strategy and effectively gain alignment across relevant stakeholders (including senior management) within Regeneron
• Evaluate and make decisions on technologies and vendors as needed to support diagnostic and program deliverables
• Provide testing site implementation and oversight for CDx programs from contracting to sample logistics to data delivery
• Develop strong working relationships with IVD partners and testing laboratories, guide and review assay validation packages, testing lab clinical trial conduct (under CAP/CLIA) and support audits of CDx testing laboratories

This Role May Be For You If

• Excellent written and verbal communication skills are essential, experience working on cross functional teams and the ability to successfully present complex strategies
• You are able to drive strategy and or projects and bring new insights to the team

To be considered for this role, you must have a Ph.D. or equivalent experience. Advanced degree strongly preferred. Minimum 7-8 years pharma/biotech or diagnostics industry experience. Technical understanding and scientific expertise in the global diagnostic landscape, including in one or more existing/emerging technologies (NGS, IHC, ELISA, FISH etc) and commercial implementation considerations for patient selection assays to help drive innovation in CDx strategy. Must have experience in execution of clinical trials, sample logistics and data reporting. Must have at least 4 years of diagnostic development experience directly supporting drug development and demonstrated working knowledge and program leadership in this space. We are need experience in biomarker discovery and development would be considered beneficial as well.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

The Statistical Programmer Provides support to the lead programmer and the study team on all programming activities according to the study requirements and the timelines. This role contributes to studies in various therapeutical areas and all clinical trial phases. The incumbent implements and executes the programming and project standard under general supervision of the lead programmer and manager to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. Maintains programming documentations such as study tracker, code, logs, and analysis outputs in a regulated environment. The incumbent may participate in and contribute to department goals and SME topics.

In this role, a typical day might include the following:

• Provide programming support within multiple studies/projects in various study activities with timely and high-quality programming deliverables in assigned tasks and projects
• Work with lead programmer and manager in cross-functional collaborations to support the study conduct and reporting activities.
• Maintain all documentation in accordance with SOPs/Guidance/WI/process to ensure traceability and regulatory compliance
• Participate and contribute towards department goals and SME topics
• Adhere to Regeneron processes and policies around retention of data, records, and information for clinical trials.
• Show commitment to and perform consistently to ensure high quality deliverables.

This role may be for you if you have

• Proficiency in SAS. Knowledge of other programming languages such as R, Python etc. is a plus.
• Good knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) is a plus
• Ability to work on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player and growth mindset

To Be Considered For This Opportunity You Will Need

MS. (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline with 1+ (2+) years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. SAS Certification a plus.

#GDBDMJobs

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Regeneron is currently looking for a Senior Industrial Engineer in the Large Scale Manufacturing Department. As a Senior Industrial Engineer, you would be responsible for identifying opportunities for improving efficiencies, decreasing waste, and developing more robust business processes. As a Senior Industrial Engineer you will also enforce and advance a culture of operational excellence and continuous improvement by working with individuals across all levels of the organization to advance our goals.

In this role, a typical day might include the following:

• Engage with the production floor to identify opportunities for improvements focused on efficiencies, wastes and costs.
• Facilitate events such as process mapping sessions, kaizens, time studies, etc.
• Educate our department on techniques and skills related to the role
• Participate in resource planning processes across the department
• Develop metrics to measure our health and abilities to meet our goals
• Present proposals and findings to the manufacturing management team
• Work cross-functionally to leverage external resources to meet our objectives
• Other duties as needed

This Role Might Be For You If You

• Have excellent communication and organization skills
• Have strong attention to details
• Are able to balance many priorities at once
• Are able to influence peers and leaders in a tactful way
• Have the ability to effectively communicate issues and ideas with peers and with management
• Have the ability to build effective working relationships throughout the organization
• Are able to facilitate meetings with cross-functional teams
• Are able to operate independently within a tight deadline environment
• Like to work in a quickly changing environment

To be considered for the Senior Industrial Engineer you must be able and willing to work Monday- Friday, 8am-4:30pm. For various levels you must have the following:

Industrial Engineer: BS/BA in Industrial Engineering or related engineering field and 2+ years of relevant experience

Sr. Industrial Engineer: BS/BA in Industrial Engineering or related engineering field and 5+ years of relevant experience

Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

We are looking for a Manager Compliance – Sourcing to supervise a team of Strategic Sourcing & Procurement Compliance Specialists that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: Leading the management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and providing secondary support to the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. Other compliance tasks/functions as assigned.

A Typical Day Might Include

• Ensures that the team of compliance employees operate as a global cohesive unit taking advantage of the efficiencies and ensuring compliance for all IOPS sites.
• Monitors, reports, and responds to Key Performance Indicators (KPIs) for the compliance functions, e.g. right-first-time (RFT) for deviation investigations.
• Performs deviation investigations and coordinates CAPA implementation as needed for high-risk events.
• Proactively manages process improvement initiatives related to all Procurement cGMP procedures, documentation and training related to SOPs and Work Instructions.
• Oversees/directs the maintenance of the Approved Supplier List (ASL) and associated Periodic Review of suppliers.
• Supplier Audit Compliance – Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures and gathering of evidence of closure for raw material and component suppliers.
• Leads the coordination with Cross Functional Compliance resources to support procurement and Quality Auditing needs for acceptable closure of Internal Regeneron and Supplier audit findings and to secure evidence that substantiates commitments. Tracks and reports CAPA in support of audit closure.

This Role Might Be For You If You Have

A Bachelor’s degree (BA/BS) with 7+ years of relevant experience, with at least 5 years of relevant experience in a cGMP environment or a Master’s degree with 5+ years of relevant experience, with at least 4 years of relevant experience in a cGMP environment. An ideal candidate will have in depth understanding of cGMP systems and processes with particular emphasis on compliance required.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

 are currently seeking an established Synthetic Chemist to lead the Regeneron Genetics Medicines (RGM) chemistry group. In this position, the Director will play a key role in building out RGM’s synthetic chemistry group in a highly collaborative environment. We expect they will act as an inspiring leader to apply chemistry solutions to address challenges related to oligonucleotide synthesis, conjugation, and LNP chemistries.

A day in the life of a Director - Synthetic Chemistry may look like:

• Leading all aspects of and mentor a group of chemists involved in solid-phase synthesis and downstream purification and analysis for different classes of oligonucleotides such as siRNAs, ASOs, gRNAs etc.
• Employing synthetic chemistry expertise to develop processes for incorporating novel chemistry and modifications to synthetic oligos (sugar modifications, base modifications, backbone modifications, linker chemistry for conjugation), at small, mid and large scale.
• Leading development of novel LNP chemistries, (design and develop novel ionizable lipids, carry out lipid modifications and conjugations, establish new processes, etc.)
• Leading all aspects of physicochemical characterization of LNP formulations and cargo
• Collaboration with Analytics and Process Development/Manufacturing/CMC groups to develop robust scalable oligonucleotide and LNP manufacturing processes
• Addressing Key regulatory CMC questions pertaining to oligonucleotide and LNP synthesis and QC
• Providing meaningful contributions to the development of an organizational culture that supports growth and development of its people and capabilities to drive forward the RGM pipeline

This Might Be The Right Role For You If

• You wan to apply expertise in developing physico-chemical analytical methods to characterize various classes of oligonucleotides and LNPs (eg. HPLC/UPLC, UV thermal melting, LC-UV-Fluor, LC-MS etc.)
• Synthesis of novel lipids and conjugating lipids with biologics/non-biologics is your passion
• You are comfortable working in a cross-functional role and excel as part of a diverse team.
• You want to provide meaningful contributions to the development of an organizational culture that supports growth and development of its people and capabilities to drive forward the RGM pipeline
• You prefer to work in an organization that is modality agnostic, letting the data determine the best course forward.

In order to be considered qualified for the role, you must:

Have a PhD in Synthetic Organic or Process chemistry, and a minimum of 10 years industry experience. 5 years of relevant experience, including a deep understanding of modern methods in synthetic chemistry with an emphasis on solid phase synthesis of oligonucleotides with various phosphonamidite chemistries using different platforms such as Mermade, DR. Oligo etc.

A track record of success in the field of oligonucleotide and LNP chemistry, with experience of building and leading a team is needed. Working in collaboration with various internal and external organisations (CROs, collaborators) is crucial. Deep expertise and proven leadership in the areas pertaining to oligonucleotide synthesis using a range of nucleoside/phosphoramidite chemistries, conjugation chemistry, and LNP chemistry will be crucial for this role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Regeneron's Therapeutic Antibody Immunoscreening group is looking for a highly motivated Sr Assoc Scientist to join our team. In this role you will contribute to the identification of potential therapeutic antibodies, in-vitro characterization and selection process of the lead molecules in early discovery stage.

A Typical Day In The Role Might Look Like

• Designing and optimizing immunoassays to assess antibody therapeutics functional properties with referencing protocols.
• Crafting cell-binding assays to categorize the diversity of antibodies in the collection.
• Implementing assays according to established protocols as a part of antibody high throughput screenings.
• Performing medium to high throughput mammalian cell binding assays and maintain mammalian and murine cell cultures.
• Optimizing assays for in-vitro quantitative characterization of the lead antibodies.
• Compile and analyze data by Excel and graphic software.
• Keep manager and the project team informed of experimental results, prepare written and oral presentations to the screening team and interdepartmental project team.
• Keep accurate records of experimental procedures and results.

This Role Might Be For You If You Possess

• Ability to multitask and perform data analysis under time pressure.
• Experience working independently as well as a collaborative team member.
• Ability to communicate effectively within a large team.
• Excellent adaptability and flexibility.
• Great attention to detail and outstanding organizational skills.

This role requires a BS or MS degree with 3-5 years + proven experience. Knowledge of immunology and protein biology and hands-on bench research/development experience preferred. A background in in-vitro protein characterization, such as ligand/receptor binding characterization and quantitative potency determination, protein structure-function relationship in the field of biochemistry or immunology is a plus. Skills in aseptic techniques and human and mouse cell culturing a plus. Experience or exposure to immunoassay and cell-based assay development (ELISA, flow cytometry, electro-chemiluminescent-based technology, high content imaging) also a plus. High throughput screening experience and familiarity with liquid handlers are beneficial.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

As a Senior Clinical Study Lead (SCSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a SCSL who has experience handling Third-Party Vendors. We need someone who can also give to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market. There are opportunities in General Medicine and Oncology.

As a SCSL, a typical day might include the following:

• Providing operational input into protocol development
• Leading all aspects of and giving to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• Ensuring compliance with the clinical trial registry requirements
• Providing input into baseline budget and timeline development and running the study against planned budget, timeline and results
• Leading risk assessment and identifies risk mitigation strategies at the study level

This Role Might Be For You If

• You have direct management experience with demonstrated results building and developing outstanding teams
• You have the capacity to understand and implement the strategic direction and guidance for respective clinical studies
• You can take a proactive and self-disciplined approach to leading projects with a developed ability to meet deadlines and prioritize
• You have a history of effectively leading and negotiating with vendors
• You have a data-driven approach to planning, executing and problem solving
• You operate with a high degree of cross-functional agility using exceptional influencing and social skills
• You have the innate ability to rally disparate groups to accomplish lofty shared goals

To be considered for this opportunity you must possess a Bachelors’ degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Associate Biotech Production Specialists are on the front line, producing our life changing products and have a passion for assisting those in need by using biotechnology. They perform all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.

What To Look Forward To

• Competitive Compensation- Regeneron offers highly competitive base pay and employees working premium shifts receive incentive pay, such as shift differential and/or weekend pay. All employees receive equity awards and are eligible for annual performance bonuses. We offer comprehensive health coverage, tuition reimbursement, and qualified employees may receive assistance paying down student loans. Relocation assistance is also available for eligible new hires.
• Work Life Balance- We provide an onsite gym and rock-climbing wall, daycare, physical wellbeing programs, tuition reimbursement, and generous paid time off and holidays.
• Emotional Wellbeing Support – Regeneron prides itself in supporting employees. We provide onsite behavioral health counselors, emotional wellbeing webinars, and Employee Resource Groups (ERGs) to all employees. Employees enrolled in any of our health plans are eligible for additional mental health support.
• Regeneron Culture- We pride ourselves on our outstanding culture! Regeneron has best-in-class onsite and offsite events throughout the year, onsite cafeterias, company affiliated sports teams and clubs, and a culture centered on diversity and inclusion.

As An Associate Biotech Production Specialist, a Typical Day May Include The Following (but May Vary Greatly Due To Regeneron’s Constantly Evolving Environment Built On Innovation)

• Includes all aspects of biotech production activities related to cell culture
• Reviews, edits, completes, and revises completed batch records, Logbooks, and SOPs in accordance with cGMP standards and aligned with written procedure
• Performs manufacturing level maintenance on equipment
• Participates in equipment start-up, commissioning, and validation activities
• Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns
• Creates process evaluation reports, process transfer documentation, and process characterization presentations
• Assist with training of new employees
• Performs in-process sampling, Quality Control Chemistry and Quality Control Microbiology
• Keeps process area stocked with essential equipment and components

This Job May Be For You If

• You want to support our amazing team to produce the highest quality medicines for patients as efficiently as possible to change people’s lives
• You are driven to challenge the status-quo and develop a culture where continuous improvement is not just a metric but rather an approach for everyone, every day, to do better
• You are not easily frustrated with a meticulous process of change control, investigations, and corrective actions
• You enjoy project oriented work with a career goal of becoming a subject matter expert
• You thrive in a fast-paced setting where your priorities can quickly change based on the needs of the business and our patients
• You are smart, adaptable and great at problem solving
• You prosper in a culture of trust, teamwork and transparency
• You are driven to constantly improve processes and procedures to find the most efficient and effective way to make it happen, everyday
• You are capable of pushing, pulling, and lifting at least 50 pounds

If you still are questioning what this role entails, please take the opportunity to view 'A Day in the Life' of one of our very own, Ashley Lebby, to learn more: https://www.linkedin.com/posts/regeneron-pharmaceuticals_learn-about-the-role-of-a-bps-and-apply-today-activity-6970862361234587648-vRzL?utm_source=share&utm_medium=member_desktop

To be considered for the Associate Biotech Production Specialist role, you must have one of the following; BS/BA in Life Sciences or related field or AS/AAS Degree/Certificate in Biotechnology/Biological Science, or an equivalent combination of education and experience.

To be considered for the Biotech Production Specialist role, you must have one of the following; BS/BA in Life Sciences or related field or AS/AAS Degree/Certificate in Biotechnology/Biological Science, or an equivalent combination of education and experience and a minimum of 2 years of relevant experience.

Level is determined based on qualifications relevant to the role.

#REGNEC

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (hourly)

$20.49 - $32.05

This role is a hybrid position on-site 2 days per week, 3 days from home.

Using extensive program management knowledge and experience in the drug development industry, the Senior Manager, Development Program Management acts as an operational lead to a team in order to meet program goals for one or more development programs [within a given Therapeutic Area]. The Senior Manager influences and carries out the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated project/program plans, goals, budgets, and timelines. The incumbent is also responsible for forming and leading effective cross functional teams and leads a network of functional area project managers.

In This Role, a Typical Day May Include

• Acting as operational lead of a program throughout its lifecycle, by integrating key collaborators from Discovery, Industrial Operations, Preclinical, Global Development and Commercial.
• Independently runs multiple and/or medium to highly complex development programs.
• Interacting with Senior Leadership.
• Partnering with the Strategic Program Lead to provide operational leadership of program(s) and supports development and execution of overall program strategy by facilitating cross-functional Strategic Development Team.
• Independently assessing and proactively addressing the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success.
• Strengthening and leading top-performing teams.
• Driving team alignment in creation of integrated project/program plans, timelines and budgets. Ensuring efficient delivery of plans.
• Directing annual program goal setting in alignment with Regeneron’s overall goals and monitoring progress against these goals. Championing potential program risks and ensuring contingency plans are in place.
• Ability to travel up to 25%

This Role May Be For You If

• You have excellent written, verbal and interpersonal communication skills with the ability to effectively interact with all levels, both within and outside the company, to establish credibility with project partners.
• You are adept at tailoring communications based on audience, effectively framing and communicating nuanced context for partners and capturing rationale for decisions.
• You actively promote constructive interactions among team members in order to address difficult situations.
• You can resolve and negotiate conflicts or problems with tact, diplomacy and composure.
• You have proven success handling multiple projects and priorities with exceptional organizational and time management skills (both project and self)
• You thrive in fast-paced environment and are comfortable dealing with ambiguity and uncertainty

To be considered, you'll need a Bachelor's degree and at least 7 years of relevant progressive project/program management experience required, preferably in the pharmaceutical or related industry. Drug development experience is strongly preferred.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.