Senior Technical Manager - Analytical Development

Roche • South San Francisco, CA

9d • $146,500 - $272,100 • Onsite

About The Position

We are seeking a highly-motivated individual with a breadth of analytical development expertise to provide scientific and technical leadership to the flow cytometry analytical development team. The successful candidate will be responsible for establishing analytical methods and implementing best practices in support of cell therapy process and product development including the development and implementation of best-in-class analytical testing strategies to control and characterize products. Operating in a cross-functional and dynamic environment, the individual will partner with Process Development, Quality Control, Manufacturing Sciences and Technology, Product Development, Regulatory Affairs, and Manufacturing teams. The ideal candidates should have experience managing daily operations of a team and implementing analytical testing methods that are compliant with regulatory requirements. This role leads a team of three Technical Development Scientists.

Requirements

• Ph.D. in Biological Sciences or other related field with 3+ years of relevant experience in the biotech and/or pharmaceutical industry preferably in cell therapy. MS/BS considered with 9+ years of relevant experience.
• Proven supervision and mentoring of analytical development teams, preferably for cell therapy products
• Strong background applying QbD principles along with practical knowledge of relevant cGMPs, ICH, and FDA regulatory framework expectations.
• Proficiency in relevant statistical methods including application of design of experiment (DOE) for development and lifecycle management of analytical methods
• Excellent interpersonal, verbal, and written communication skills including experience authoring CMC regulatory documents
• Proven hands-on expertise with multicolor flow cytometry, cell-based assays, or complementary platforms (e.g., qPCR, ddPCR, ELISA, NGS)
• Thrives in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

Nice To Haves

• Expertise in stem cell biology, immunology and/or cancer biology is strongly preferred

Responsibilities

• Lead and execute studies for the selection and development of robust, state-of-the art multicolor flow cytometry methods and cell-based assays to monitor final product quality attributes and process performance.
• Represent analytical development team in CMC and program meetings to facilitate the completion of goals
• Manage method and analytical technology transfer to the GMP QC team and external partners
• Enable a collaborative work environment with key groups to support analytical method development as well as the characterization of cell therapy products
• Provide training, mentorship, and support to other teams developing flow cytometry methods, as a technical expert
• Maintain knowledge of industry trends and critically evaluate analytical technology platforms, single cell analysis technologies and scientific literature in order to contribute maximally to cell therapy analytical development efforts.
• Draft technical reports, standard operating procedures, and test protocols in support of analytical development.
• Enable successful completion of key program milestones through individual contributions and supervision of team of analytical development scientists

Benefits

• Relocation benefits are available for this job posting.
• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree