Longevity Industry Jobs

This role will provide planning, management and executional leadership and support in relation to CMC, Quality and Regulatory activities in preparation of INDs, BLAs and other regulatory documents/applications submissions. The individual for this role must be project management expert and possess strong leadership skills. The responsibilities of primary importance are to ensure the successful and time-sensitive planning, compliance, and overall program management and operational support of all activities.

Responsibilities

• Work with senior management to assess current CMC pathway to registration for Capricor’s therapeutic product candidates.
• Establish and direct vision and lead all aspects of setting plans, timelines, identifying risks and constraints with respect to CMC activities.
• Partner with leadership to develop and refine project plans including schedule, budgetary baselines and risks.
• Actively manage risks, reporting and establish program mitigation plans.
• Incorporate PM guidelines and mentor cross-functional teams as needed.
• Present project and program governance plans to management and obtain approval as needed.
• Manage and coordinate necessary activities to deliver BLA submission according to the established milestones and FDA guidelines.
• Communicate status of activities to executive leadership team and appropriate team members on a regular basis
• Ensure alignment, collaboration, execution and delivery across the cross functional teams.
• Support all regulatory submission activities to ensure milestones are met.
• Assist in planning, coordinating and contributing to meetings with regulatory agencies.

Requirements

• Master’s or Ph.D. preferred
• 10+ years of hands-on cGMP biologics manufacturing experience in pharmaceutical/biotech industry
• Strong scientific background with deep knowledge of biologics, specifically cell therapy experience a plus
• Must have full working knowledge of cGMP and applicable FDA regulations
• Exceptional communication and interpersonal skills
• Ability to collect and analyze data and information to determine paths for process improvement and potential root cause analysis
• Demonstrated critical thinking and problem-solving skills
• Ability to deliver to a high standard of quality
• Ability to manage multiple projects simultaneously, with ability to prioritize in a fast paced, dynamic environment

We are seeking highly motivated candidates who are capable of independent work in a collaborative environment for a Quality Control Associate II. This position will need to perform QC testing of existing products, coordinate shipping of samples for outsourced testing, perform data analysis, assemble and complete QC data documentation, perform OOS investigations, and assay qualifications. This position will also collaborate with the development group in developing new assays and analytical methods. Products may include cells, exosomes, and other regenerative therapeutics.

Responsibilities

• Perform QC analysis testing on current products to support batch disposition, including testing on in-process intermediates, final formulated bulk drug substance and final drug product
• Interface with outsourced laboratories to coordinate sample receipt, testing, and on time reporting of results
• Prepare and maintain mammalian cell cultures
• Perform data analysis, organize records, reports and databases in a timely manner
• Write technical reports or documentation such as deviations, qualification/validation protocols, and investigation of OOS results
• Collaborate with Process/Analytical Development to troubleshoot and optimize current assays and future analytical methods
• Train other employees to perform relevant techniques and procedures as needed
• Write or revise quality control Standard Operating Procedures
• Carry out Environmental Monitoring of manufacturing facility and relevant samples generated.
• Coordinate with third party vendors to maintain calibration of equipment
• Work closely with the Manufacturing and Quality Assurance department staff to resolve issues regarding the facility and products manufactured
• Present data internally
• Receive and inspect materials
• Work under minimal supervision to meet project goals; and
• Other duties as assigned

Requirements

• Bachelor’s degree in a relevant Biological Science discipline
• 3+ years of experience working in a GMP Quality Control laboratory or a combination of experience in a GMP/GLP setting is preferred
• Mammalian cell culture methods and molecular biology skills
• Experience with laboratory methods including flow cytometry, Western Blot, qPCR, RNA/DNA isolation, ELISAs, endotoxin detection etc
• Experience with method qualification/validation is preferred
• The ability to independently perform laboratory analysis, troubleshoot, and improve methods
• Demonstrated history of successful, independent laboratory work
• Excellent communication, time-management skills and the ability to work as part of a team
• Ability to work with Outlook, MS Office, and other electronic systems
• Ability to gown and work in a classified area. Aseptic processing a plus

A position is immediately available for a Quality Control (QC) Associate III /Senior QC Associate to lead the stability program and sample management and perform QC testing, data analysis, OOS investigations, environmental monitoring, and assay qualifications/validations. The incumbent will also collaborate with the development group in developing new assays and analytical methods. Products may include cells, exosomes, and other regenerative therapeutics. We are seeking highly motivated candidates who are capable of independent work in a collaborative environment.

Responsibilities

• Establish and lead the stability program for new and existing products
• Establish and lead sample management
• Write technical reports or documentation such as deviations, qualification/validation protocols, and investigation of OOS results
• Collaborate with Research and Product Development Department to troubleshoot and optimize current assays and future analytical methods
• Perform QC analysis testing on current products to support batch disposition, including testing on in-process intermediates, final formulated bulk drug substance and final drug product
• Manage relationships with outsourced laboratories to coordinate sample receipt, testing, and on time reporting of results
• Work closely with the Manufacturing and Quality Assurance department staff to resolve issues regarding the facility and products manufactured
• Prepare and maintain mammalian cell cultures
• Perform data analysis, organize records, reports and databases in a timely manner
• Train other employees to perform relevant techniques and procedures as needed
• Write or revise quality control Standard Operating Procedures
• Carry out Environmental Monitoring of manufacturing facility and relevant samples generated
• Coordinate with third party vendors to maintain calibration of equipment
• Work under minimal supervision to meet project goals
• Present data internally
• Receive and inspect materials
• Other duties as assigned

Requirements

• 5+ years of experience working in a GMP Quality Control laboratory or a combination of experience in a GMP/GLP setting is required
• Experience with mammalian cell culture methods and molecular biology skills
• Expertise with laboratory methods including flow cytometry, qPCR, RNA/DNA isolation, ELISA, endotoxin detection etc
• Experience with method qualification/validation is desired
• The ability to independently perform laboratory analysis, troubleshoot, and improve methods
• A history of successful, independent laboratory work
• Excellent communication, time-management skills and the ability to work as part of a team are required
• Excellent project management and organizational skills
• Strong ability to lead teams and manage QC specialties, stability program, sample management
• Operational Excellence skills, eg 5S, lean, desired
• Computer literate. Ability to work with Outlook, MS Office, and other electronic systems
• Ability to gown and work in a classified area. Aseptic processing a plus
• A Bachelor’s degree in a relevant Biological Science discipline is required

We are seeking a highly motivated self-starter individual to join our team as a Director, Biostatistics. This individual will actively contribute and lead all major projects, analyze all parts of any clinical study, and provide planning on clinical studies. The selected candidate will be responsible for statistical programming, contributing to the quality assurance of statistical analyses, writing methods and analysis descriptions in formal reports, communicating with collaborators, and organizing and maintaining confidential project materials.

Responsibilities

• Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence
• Support is the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represent the Biostatistics function for cross-functional and intra-departmental teams or working groups
• Functions as the lead statistician for assigned clinical projects
• Performs management of in-house and/or outsourced biostatistical activities
• May engage with regulatory authorities on compound/indication level discussions
• Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed
• Create programs for data management activities, compliant analysis datasets, and statistical analysis of the clinical trial data
• Prepare the statistical section of clinical trial reports and presentations of the results to the team
• Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development
• Presenting interim trial data to Data Monitoring Committees (DMCs)
• Writing statistical reports and memos with minimal guidance
• Programming complex datasets
• Leading sophisticated analyses, including efficacy and futility interim analyses for DMCs
• Prepares and documents facts to enable management to write and support trial reports and publications
• Ensures that new and revised statistical standards, tests, and processes are implemented for increased accuracy and efficiency
• Reviewing statements of work, proposals, and budgets.
• Mentoring of lower-level employees
• Managing multiple projects and a majority of own workload
• Other duties as required.

Requirements

• Master's Degree in statistics, biostatistics or a closely related field; PhD preferred
• 10+ years clinical trials experience
• Experience with rare disease and NDA/BLA submission preferred
• Strong knowledge of statistical software packages including SAS and other statistical and database and reporting applications such as Splus, R, and SQL
• Strong knowledge of therapeutic area and acute care/hospital trial settings preferred
• Demonstrates strong leadership and management skills
• Ability to write and articulate clearly
• Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives
• Ability to prioritize workload to meet multiple project timelines
• Excellent planning and organization skills
• Excellent problem-solving abilities
• Ability to function independently and exercise judgment and decision-making skills

This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support Capricor’s clinical trials and exosome development. We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.

Responsibilities

• Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
• Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
• Compiling data for documentation of test procedures and reporting abnormalities
• Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
• Authoring, revising and updating standard operating procedures using the document change system
• Maintaining broad knowledge of state-of-the-art principles and theories
• Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations
• Preparing technical summaries, protocols and reports
• Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
• Performing special manufacturing and development projects

Requirements

• Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field
• 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
• Laboratory experience in mammalian tissue culture is required
• Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
• Exceptional communication and interpersonal skills
• Excellent organizational skills and attention to detail
• Ability to work in a dynamic environment
• Basic molecular biological and flow cytometry skills are preferred
• Adaptable/flexible with work schedule with an ability to multi-task and prioritize work
• From time-to-time extended hours may be required with or without notice, dependent on the work needed

This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support Capricor’s clinical trials and exosome development. We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.

Responsibilities

• Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
• Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
• Compiling data for documentation of test procedures and reporting abnormalities
• Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
• Authoring, revising and updating standard operating procedures using the document change system
• Maintaining broad knowledge of state-of-the-art principles and theories
• Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations
• Preparing technical summaries, protocols and reports
• Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
• Performing special manufacturing and development projects

Requirements

• Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field
• 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
• Laboratory experience in mammalian tissue culture is required
• Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
• Exceptional communication and interpersonal skills
• Excellent organizational skills and attention to detail
• Ability to work in a dynamic environment
• Basic molecular biological and flow cytometry skills are preferred
• Adaptable/flexible with work schedule with an ability to multi-task and prioritize work
• From time-to-time extended hours may be required with or without notice, dependent on the work needed