Job Listings

Director/Associate Director, Process Development

Process Engineer

We are seeking an experienced and motivated Process Engineer to represent Genocea Biosciences at contract manufacturers’ facilities and to ensure the company’s interests are protected. This individual will provide technical and troubleshooting support for manufacturing-related activities, support evaluation and RFP process for selection of Contract Manufacturing Organizations (CMOs) and support technology transfer activities in conjunction with contract manufacturers.

Responsibilities for this position include:

Representing Genocea Biosciences on site at CMO facilities
Providing oversight of development and manufacturing operations at CMOs related to Genocea’s programs
Assisting in troubleshooting process and equipment-related issues
Facilitating communication between Genocea and CMO to ensure rapid and correct decision-making and agreement on procedures and activities to be carried out
Supporting evaluation and RFP process for selection of CMOs
Supporting technology transfer activities
Reviewing and commenting on technical documents related to production, testing, facility and equipment validation status, etc, as necessary
Providing oversight of Genocea program activities sub-contracted by CMOs (viral clearance, analytical testing, etc), as appropriate
Performing lab-based process development activities, as required
Supporting preparation of regulatory documents, as required
Interfacing with Process Development, Protein Biochemistry and Analytical/Formulations groups to align work flows and integrate activities to most effectively support Genocea projects

Required Skills

Excellent communication, problem solving and analytical skills. Strong organizational skills and ability to multi-task
Experience with biologics manufacturing operations and familiarity with relevant equipment
Familiarity, or preferably, direct experience with various upstream and downstream process technologies
Solid understanding of CMC compliance requirements and quality systems in a GMP manufacturing setting
Experience in biologics process development and manufacturing; vaccines experience is preferable
Experience with early stage biopharmaceutical process development is highly valuable

Education & Experience

Masters degree in related field, with a minimum of 8 years industry experience

Interested and qualified for this position? Please click here to email us

Director/Associate Director, Process Development

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.

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. 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. This position also requires excellent organizational and interpersonal skills as well as team leadership abilities.

Responsibilities for this position include:

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.

Required Skills

Experience with state-of-the-art separation technologies including clarification and purification modalities such as Tangential Flow Filtration (cassettes and hollow fibers), chromatography, 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.
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 also possess excellent presentation and writing skills.
A roll-up-the-sleeves approach to problem solving and team leadership.

Preferred Skills

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 scalability.

Education & Experience

Ph.D. in Biochemistry, Biotechnology or Biochemical Engg.
8-10 years experience in industry in a biologics process development setting focused on purification development
Vaccines experience preferred.

Interested and qualified for this position? Please click here to email us