As an expert in analytical development of gene therapy biologics, the Associate Director/Director, Analytical Development directs the efforts of a team of scientists and RAs in the development of analytical methods to determine the purity, potency, strength and identity of drug substance, drug product and process intermediates. The scope of this position currently focuses on R&D and early clinical development, but later it will extend to commercialization and life cycle management.
- Identifies, strategizes, prioritizes and manages analytical development activities to resolve a variety of complex problems.
- Communicates and consults with key personnel in QC, executive management, Pharm/Tox, Research, Regulatory and Clinical. Keeps peers and management informed about analytical issues and their impact on project timelines.
- Manages Analytical Development (AD) group efforts, including assay development, method qualification and transfer to QC, and assay support of Process Development and other groups as needed. Mentors Scientists and Research Associates.
- Provides scientific and operational advice to AD personnel to facilitate their assay development activities.
- Primary contact representing AD to other departments, including Process Development, Regulatory, Manufacturing, QC, QA, Pharm/Tox, Research and senior management.
- Authors and reviews relevant analytical sections in IND/IMPD/BLA/MAA (analytical procedures, justification of specifications, impurities, characterization etc.)
- Ensure a continued information flow among other departments and external collaborators/partners
- Represents Tenaya Therapeutics’ AD group at regulatory authority meetings and teleconferences for analytical questions
- Maintains an awareness of new technology that could benefit the AD group, and brings in new technology as appropriate.
- Management responsibilities include oversight of day-to-day activities; budgeting; performance reviews; and mentoring/career development.
- Acts as team or project representative on external collaborations and with contract laboratories.
- Presents and discusses issues, solutions and results at department and project team meetings
- Presents at external meetings or publishes in peer-reviewed journals
- PhD, MS or BS in Analytical Chemistry, Chemistry, Biochemistry, or related discipline
- Requires a minimum of 3 years experience as an analytical development scientist or manager in biologics development
- Highly prefer Analytical Development or Quality Control experience with Adeno-associated virus (AAV) and/or Lentiviral drug development. Cell therapy experience would be equally relevant.
- Excellent communication, interpersonal, organizational, writing, and managerial skills
Regulatory Agency Interaction Experience Preferred
Key Skills, Abilities, and Competencies
- Analytical sciences, method development, and assay qualification experience
- Strong organizational skills and attention to detail for composing and proofing relevant documents, materials, scheduling, establishing priorities and meeting deadlines
- Motivation/desire to work in a fast-paced, small-company environment.
Tenaya takes into account a wide range of factors when determining compensation including but not limited to skill sets, experience, interview performance and organizational need.
We will make an offer based on geo-located salary bands based on data collected from Aon/Radford. As of 1/1/2023, for individuals assigned and/or hired to work in the San Francisco Bay Area in the state of California, your base salary will fall within the band(s) below. This base salary range is an estimate, and the actual base salary may vary based on Tenaya’s compensation practice. Please also remember that the benefits, bonus, and equity portion of your offer is not included in these numbers and represent a significant portion of your total rewards package at Tenaya. Should you reach the verbal offer stage of Tenaya’s hiring process, we will review the base salary, benefits, bonus target and equity grant value with you at that time. Associate Director range is $147,000 – $262,500. The Director range is $161,000 – $287,500. Senior Director Range is $185,500 - $331,250
We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.
We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time, and holidays.
State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.
Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.
Tenaya is proud to be an equal opportunity workplace.