Manager, Assays and Analytics | Thermo Fisher Scientific | San Diego

Requisition ID: 157659BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information
San Diego CA / Pharma Services Group – Viral Vectors Business Unit

How will you make an impact?
The Science & Technology Team (STT) is passionate about developing end-to-end, standardized workflows and assays to support nucleic acid, viral vector, and cell therapy cGMP manufacturing. The Manager will be responsible for building and leading a robust technical team passionate about supporting analytical method development, and execution of cellular-, molecular- and chemistry-based assays that support quality control of cell and gene therapy products under development and on a path towards GMP manufacturing. The position requires knowledge of standard procedures used in process and product characterization, assay development and execution.

What will you do?
• Be responsible for establishing a modern analytical laboratory capacity, lab operations and internal technical transfers. Establish QC and operational metrics, assess existing methods/processes and identify areas for innovation and expansion
• Will have budgetary accountability to ensure operational and capital expenditures are aligned with corporate expectations.
• Develop and execute a variety of analytical methods to establish in-process, release and stability tests. Directly or coordinate review experimental design, execution, data and reporting of work completed.
• Address and resolve technical issues in concert with the Technical Head of STT Translational Services, STT colleagues, collaborators, and clients
• Utilize Quality by Design tools in assay design and development, evaluate functional strengths and development areas for continuous improvement
• Generate protocols and reports for method transfer, assay qualification, and data analysis and reporting.
• Understand project timelines and results and plan/coordinate project work accordingly with departmental, functional and external partners.
• Lead QC lab, delegate and share lab management duties. Develop appropriate operating and capital expense budgets
• Hire, train, mentor and lead scientists and technicians involved in analytical development and QC testing. You will provide strong leadership, mentorship, and scientific oversight to internal team members.
• Work in a matrix environment, interact externally and internally across technical teams, divisions and different functions, connect with clients and support translational services

How will you get here?

Ph.D. and post-doctoral experience in Biochemical Engineering, Microbiology, Biochemistry, Cell Biology, and/or molecular biology required with 2+ years or Master’s degree with 7+years hands-on experience.

• Experience working in a multi-disciplinary team with at least 2 years of supervisory experience. Prior experience in viral vector or cell therapy is required
• Strong technical background in analytics based upon experience
• Strong leadership skills in organization structure, team building, cross-functional communication and accountability. Strong people management; ability to prioritize and lead through sophisticated processes/projects.

Knowledge, Skills, Abilities
• Proficiency with commonly used analytical instruments and methods such as flow cytometry, PCR, qPCR, ddPCR, ELISA, HPLC, cytotoxicity assay
• Hands-on experience with method development, SOP and test record development, laboratory equipment and calibration, some knowledge of cGMP requirements for biopharmaceutical manufacturing
• Strong communication, open to suggestions and feedback, highly collaborative with the ability to adapt to change, work within a team with varied strengths to effect performance

NOTE: Position may require Covid-19 vaccination and/or routine testing, per client discretion. As a requirement to be onsite at Thermo Fisher Scientific this position requires vaccination status disclosure upon employment.

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status