Director, Analytical Development
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.
The Director of Analytical Development (AD) will serve as a key member of the Technical Operations organization. This individual will be responsible for helping to build the analytical development team within Lyell, as well as partnering closely with the research, process development and manufacturing organizations. This includes the recruitment and training of AD scientists, the establishment of various technologies, such as flow cytometry, cell-based assays, analyte/cytokine measurements, transcriptional analyses etc. Assessment of new technologies, technology transfer of test methods to the QC testing facility and other key projects required to help build and grow the Technical Operations division.
We are recruiting a talented and experienced Director of Analytical Development to help build our expertise in the Technical Operations organization. S/he will work closely with Lyell Tech Ops, Manufacturing and Research groups to develop a high functioning AD group, including establishment of the infrastructure (technology and equipment), hiring and training members of the team and assisting in the tech transfer of CAR-T-based analytical methodologies into a new GMP manufacturing and QC testing facility. The successful candidate will have experience in AD activities in the cell and gene therapy space (preferably), ability to mentor scientists, experience with assessing new technologies, experience with CMC project timelines and activities, experience in preparing and managing annual operating plans and budgets and a thorough understanding of the technological requirements to execute on the analytical testing and characterization needs of a cellular therapy company.
KEY ROLE AND RESPONSIBILITIES:
- Play critical leadership role in the establishment of the analytical development group within the Technical Operations division at Lyell, including recruitment and training/mentoring of other analytical scientists, determining critical equipment and technology needs and infrastructure and building relationships with key stakeholders, including research, process development and quality control functions
- Design, develop, execute and document analytical methods to study and characterize processes for production of T cell therapies
- Lead analytical projects including but not limited to development of analytical control strategies and heightened characterization of cell therapy products
- Serve as key technical resource for the evaluation of new analytical technologies and their implementation within the AD group
- Revise, review, and author assay standard operating procedures
- Lead product characterization activities, including comparability assessments in support of product life cycle management
- Act as subject matter expert in providing analysis and data interpretation both internally and externally
- Partner in the transfer of qualified assays to QC, and support assay validation and assay trouble shooting
- Provide analytical support in cross-functional project teams, investigation teams and CMC teams
- Develop and deliver scientific presentations, prepare clear and concise technical reports, participate in project teams, and contribute to regulatory filings
- Contributes to building a culture that encourages continuous learning, improvement and innovation, and encourages team members to expand their technical skill base
- Ph.D. in Molecular/Cellular Biology, Immunology, Biochemistry, Biology or equivalent relevant industry experience with a MS or BS degree
- A minimum of 12 years of experience in analytical development, cGMP QC testing and/or CMC development or other relevant discipline(s)
- Experience in analytical development, cGMP QC testing and implementation of new technologies in a regulated environment (e.g., GMP, GLP, GxP)
- Experience with the assessment of new technologies in a fast-paced, learning organization; preferably in a cross-functional setting where impact of new technologies are evaluated across research, development and commercial organizations
- Prior experience in either design, qualification, start-up of analytical development labs preferred
- Cell therapy experience
KNOWLEDGE, SKILLS AND ABILITIES:
- Must have excellent oral and written communication skills
- Ability to work independently and collaboratively among cross-functional teams
- Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
- Excellent analytical skills and scientific/technical expertise
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.