Associate Director/Director, Upstream Process Development

We are looking for an Associate Director/Director of Upstream Process Development to join our growing South San Francisco team!

Summary:

The Associate Director/Director of Upstream Process Development is responsible for designing, executing, and reporting experimental activities in the cell culture process development laboratory, with a focus on developing a next generation Ad5 production process. The Director troubleshoots existing platforms, consults with manufacturing operations, and communicates progress and results to senior management via technical reports and/or presentations. The Director also works closely with the Downstream, Formulation Development, and Manufacturing teams to define unit operations that fit manufacturing constraints and corporate timelines. The person in this role is expected to work with in-house and partnering development and manufacturing organizations in tech-transfer and manufacturing support roles. The Director trains and mentor’s junior scientists to take a leading role in designing and organizing the Cell Culture Process Development laboratory and to establish a culture of general compliance, safe operations, and proper documentation and communication of results.

Responsibilities:

• Develop/direct robust, scalable, well characterized, and cost-effective upstream processes for the biologics pipeline.
• Manage process development staff and contract service providers in upstream drug substance process development activities and technology transfer to Manufacturing.
• Lead process characterization/validation studies (including scale-down models and design of experiment approach to identify critical process parameters) and process validation, including review of development, process characterization, and validation protocols and reports.
• Perform, instruct, and direct others in mammalian cell culture and virus production.
• Assist with the development of robust and cost-effective commercial scale production processes.
• Writes and/or reviews protocols, development reports, batch records, standard operating procedures, and other technical reports in support of manufacturing and process tech transfer. Ensures that results are properly archived and communicated.
• Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters.
• Evaluate new technology and procedures.
• Manage and train staff as appropriate in laboratory activities.
• Ensure that training and compliance records are kept updated for themselves and staff and ensure that all safety procedures are followed.
• Proactively communicates with internal and external stakeholders.
• Ensure high quality source documentation to support global regulatory filings, including writing/reviewing).

Requirements:

• Ph.D. in Bioengineering, Biochemistry, Chemical Engineering, Biological Sciences, Microbiology, or closely related field.
• 7+ years of relevant industrial experience in product quality, scale-up, and large-scale manufacturing of recombinant proteins and anti-bodies.
• A minimum of 2 years’ experience managing and leading teams.
• Demonstrated large-scale mammalian cell culture-based bioprocess, technology transfer, and manufacturing experience required.
• Strong background and subject matter expertise in upstream unit operations, including cell line development, fed batch, and perfusion cultures, bioreactor operations, and impact of process conditions.
• Knowledge of cGMP and regulatory requirements related to biologics manufacturing and controls, including authoring relevant CMC sections of IND/BLA filings.
• Extremely detail-oriented, thorough, and diligent in experimental design, data analysis, and review.
• Familiarity with production and purification of viral products.
• Experience with stirred-tank bioreactor operations and control.
• Excellent interpersonal skills with the ability to collaborate cross-functionally and gain the cooperation of others.
• Excellent presentation and written and verbal communication skills.
• Experience and knowledge of QC issues.
• Expertise sterile techniques and hazardous/infectious material handling.
• Excellent organizational skills and ability to execute on multiple projects
• Ability to work in a high impact, fast-paced, and lean biotech start-up environment.
• Familiarity with viral vector production is highly desired.