Principal Scientist - Cell Therapy Drug Product Process Development

Roche • South San Francisco, CA

1d • $120,800 - $224,300 • Onsite

About The Position

The Cell and Individualized Therapies Department has an exciting opportunity for a Principal Scientist with a strong background in cell therapy drug product process development. The selected candidate will work as a part of the Cell Therapy Drug Product Process Development Team that is responsible for optimizing the formulation and drug product processing unit operations and clinical administration procedures for allogeneic CAR T cells, retinal pigment epithelial cells, and other cell therapy modalities. This “Lead from the Bench” position requires effective participation in cross-functional teams with members from Genentech Research and Early Development (gRED), Cell Therapy Engineering and Process Development (CTED), Analytical Development and Quality Control (ADQC), Manufacturing Sciences and Technology (MSAT), Quality, and Regulatory departments.

Requirements

• BS/MS/PhD in Biochemistry, Biology, Chemical Engineering, Bioengineering or Pharmaceutical Technology or related discipline
• Approximately 7-10+ years of cross-functional pharmaceutical development experience in drug product process development and/or cell therapy process development with practical knowledge of fill/finish manufacturing processes (includes time spent in PhD program/post doc position)
• Experience developing processes for or characterizing therapeutic human cells in a pharmaceutical development setting (ex. CAR-T cells, regenerative cells, etc.)
• Knowledge of state-of-the-art cell characterization assays (e.g. multi-color flow cytometry) and aseptic technique
• Strong background in the relevant unit operations including formulation, sterile filtration, sterilization, aseptic processing, single-use systems, filling, visual inspection, controlled rate freezing/thawing and cryopreservation, and clinical administration procedures
• The candidate must be highly self-motivated, have excellent organization, oral and written communication skills, and be willing to work both independently and as a team member
• The candidate must be willing to work in a dynamic, fast-paced environment, and be capable of handling multiple tasks while meeting timelines

Nice To Haves

• Prior experience with technology transfers, process validation and risk assessments is highly desired
• Has an overall end-to-end understanding of the drug development process; is able to identify similar problems across different functions and begin to implement cross-functional strategies

Responsibilities

• Independently design, execute, and interpret process development studies related to drug product unit operations for multiple cell therapy products with minimal supervision
• Identify potential process improvements and initiates projects after receiving buy-in from relevant stakeholders on the scope, timing, and resource requirements
• Support development and implementation of new processing equipment, as needed
• Support the process transfer of drug product manufacturing unit operations to multiple manufacturing site(s) in close collaboration with MSAT colleagues
• Support the development of clinical thawing and administration procedures, and respond to related inquiries from clinical sites
• Serve as a functional representative on multiple cross-functional teams and ensure strategy and timeline alignment for key work packages
• Author and review technical reports, process validation documents, and significant portions of regulatory submissions to support ongoing clinical trials and licensure
• Guide and influence the work of more junior team members
• Collaborate with research colleagues to assess the manufacturability of new modalities in the research portfolio
• Act as a resource within the department in multiple areas of expertise

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: Principal
• Education Level: Ph.D. or professional degree