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Genezen · 2 days ago

Scientist II, Upstream Process Development

Lexington, MA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $120K/yr

4+ years exp

Genezen is a rapidly growing company in the field of gene therapy, specializing in process development and GMP viral vector production. The Scientist II in Upstream Process Development will direct the development of scalable viral vector production processes, ensuring quality and safety while collaborating closely with internal teams.

BiotechnologyGeneticsManufacturing

No H1B

Responsibilities

Design and execute upstream process development activities and identify opportunities to improve process yield, product safety, and product quality

Writes and reviews experimental protocols, batch production records, experimental reports

Analyze, review, and communicate data to senior management and team members

Be accountable for supporting the establishment of upstream gene therapy drug substance development platform from small scale through intermediate scale (50L) for adeno-associated virus, lentiviral and retroviral vector processes

Train and mentor research associates

Maintain open communication via one-on-one and team meetings

Stay current with relevant technologies and need to be adept at identifying new approaches

Responsible for the process transfer activities from/to clients and to in-house manufacturing team(s), such as creation of bill of materials and sampling plan, generation of process description documents, technology transfer reports.Provide process training to MSAT and manufacturing teams and assist with process troubleshooting and deviations during GMP production

Maintain external technical relationships and collaborate with equipment and material suppliers

Serve as process SME for client-facing and internal programs

Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area

Qualification

Cell culture technologiesUpstream processingCGMP manufacturingBiochemical engineeringMolecular biologyAseptic processingGene therapyProcess developmentTechnical supportEntrepreneurial experienceMulti-disciplined teamsDetail-oriented

Required

BS or MS in biochemistry, chemical engineering

4-8+ years of relevant industry experience

Experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing

Pharmaceutical industry experience in technical support of cGMP manufacturing and/or process development, including experience with Contract Development and Manufacturing Organizations

Entrepreneurial experience dealing with customers in product development

Working knowledge of Upstream process (Cell culture, Aseptic Technique, bioreactor operations)

Hands-on experience on complex biologics e.g. gene therapy, transient transfection, baculovirus infection

Ability to interface successfully with multi-disciplined teams

Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools

Adaptability required as work schedule may change based on business needs

Criminal background check required