Technical Development Principal Scientist

Position: Technical Development Scientist III/ Technical Development Principal Scientist

Reporting to: Sr. Director Analytical Development

Grade: SE6

Position Summary

We are seeking an experienced and motivated Scientist III to join the Analytical Development team at Genentech San Diego. This position works with the PTCC team to develop robust analytical methods for cell product characterization and release. The Analytical Development Scientist III will develop and use state-of-the art analytical methods assay to characterizae cell therapy products and processes. The successful candidate will critically evaluate scientific data and study protocols, will lead initiatives, and take part in cross-functional teams acting as subject matter expert. In addition, this individual will be accountable for ensuring that analytical methods and data are fit-for-purpose.The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.

Responsibilities may include but are not limited to:

• Develop or adapt analytical methods for cell therapy product release and characterization by designing and executing studies via design of experiment (DoE).

• Design and execute exploratory experiments to better understand and define CQAs and optimize current analytical methods.

• Independently research, plan and execute experiments and analyze data to determine next course of action and make recommendations to internal and inter departmental audiences.

• Perform risk and gap assessments for analytical methods and aim to enhance compliance and robustness.

• Execute routine laboratory experiments in collaboration with more junior technical staff to generate high quality data by following best practices of assay and instrument operations.

• Perform data analysis and document study outcomes and conclusions, summarize and present to key stakeholders.

• Design, execute, and approve method development, transfer, and qualification in support of process development, product characterization, product release and stability.

• Lead lifecycle management of analytical assays by trending the data assigning appropriate controls.

• Author SOPs, assay development and qualification reports and regulatory documents. Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of analytical data to support regulatory filings.

• Work with a cross-functional team to advance development of cell therapy products.

• Support training of junior Research Associates or other team members, as needed.

Requirements, Knowledge, Skills and Abilities:

• Masters degree with 6-9+ years experience in analytical development, QC, technology transfer and method lifecycle management or Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Molecular Biology Biochemistry, or related field) with 2+ years of industry experience.

• Expertise in flow cytometry and immunology analytical method development, method transfer to QC labs is required

• Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies and method qualification/validation

• Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE)

• Ability to interpret and apply ICH guidances, cGMP, USP, regulatory requirements and industry best practices for analytical method development, technology transfer, method qualification/validation and process development.

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

• Excellent interpersonal, verbal and written communication skills are essential.

• Self-motivated, detail-oriented, and willing to accept responsibilities outside of initial job description.

• Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams.

• Ability to think critically and demonstrated troubleshooting and problem-solving skills.

• Attention to safety, good laboratory practice, and good documentation practice.

Preferred Qualifications

• Two plus years of relevant cell therapy industry experience

• Experience with analytical control systems for stem cell and T cell products

• Experience with one or more of the following analytical techniques: ddPCR, qPCR, cell imaging, reporter-based potency, cell engineering, Next-Generation Sequencing, and metabolic analysis