Director/Associate Director, Process Development Genocea Biosciences, Inc.
THIS JOB HAS EXPIRED Job Summary
We are seeking an experienced and motivated Director/Associate Director, Process Development to lead the process development efforts in support of the development of protein-based vaccines for the prevention and treatment of infectious diseases with significant impacts on human health.
Experience with state-of-the-art separation technologies including clarification and purification modalities such as chromatography, Tangential Flow Filtration (cassettes and hollow fibers) and sterile filtration.
Experience with cGMPs, viral clearance strategies and study designs, DOE approach to process optimization and current Quality by Design (QbD) initiatives.
Experience with technology transfer and interfacing with external contract organizations.
Experience developing manufacturing processes in various production systems (e.g. E. coli, yeast, mammalian and insect cells).
Experience with cell line and production strain selection and preparation of cell banks and viral seeds.
Experience with bioreactor process development aimed at optimizing process productivity, consistency and scaleability.
Must work well within a dynamic and team-oriented start-up environment.
Must have a track record of timely delivery on process development milestones.
Must possess excellent organizational, management and interpersonal skills.
Must possess excellent presentation and writing skills.
Must possess a roll-up-the-sleeves approach to problem solving and team leadership.
Applicants should have a Ph. D. (Biochemistry, Biotechnology, Biomedical Engg, Biochemical Engg) with 8-10 years industry experience in biologics process development with an emphasis on protein production. Vaccines experience preferred.
A strong background in downstream process development with an excellent understanding of and experience with GMPs, various process technologies, scale-up considerations, DOE approach to process optimization, current Quality by Design (QbD) initiatives and technology transfer are required. Experience with upstream process development is also desired.
Formulate process strategies for new vaccine programs entering development and scale-up strategies for those entering more advanced stages.
Support technology transfer of processes to contract manufacturers for development and production of toxicology and Phase I and II clinical batches.
Provide or oversee technical support and troubleshooting for PD and manufacturing at contract facilities.
Prepare technical documents to support regulatory filings, technology transfer, etc.
Lead Process Development function and manage staff.
Act as the Process Development lead and subject matter expert for internal planning and technical discussions
Act as the Process Development representative for interactions with contract manufacturers, collaborators and other parties
Represent the Process Development group on multidisciplinary project teams and other internal forums.
Interface efficiently and effectively with the Protein Biochemistry and Analytical & Formulation Development groups within the Development department.
||161 First Street |
Cambridge, MA 02142
THIS JOB HAS EXPIRED