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Genezen · 1 day ago

Scientist II/III, Downstream Process Development

Lexington, MA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $130K/yr

2+ years exp

Genezen is a company focused on gene therapy and process development, providing GMP viral vectors for clinical trials. The role involves directing the development of processes for viral vector production, ensuring scalability and compliance with industry standards while collaborating closely with internal and external stakeholders.

BiotechnologyGeneticsManufacturing

No H1B

Responsibilities

Accountable for supporting the establishment of downstream vector platform from small scale through intermediate scale (50L) for adeno-associated virus, lentiviral and retroviral vector processes

Monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality

Support process optimization efforts leading to increases in process robustness, cost reduction and improvements in viral yield and purity

Design and execute experiments independently: accurately record, analyze, and communicate data to senior management and team members

Frequently communicate with external clients to design experiments and report out on generated data

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

Stay current with relevant technologies and client/industry including identifying new approaches

Perform and lead single-use system design manifold, selection, implementation, configurations in between Upstream bioreactor and downstream unit operations and control strategies

Develop appropriate and detailed SOP and BPR for downstream processes including equipment and system use

Responsible for the process transfer from/to clients and to in-house manufacturing team(s)

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

Biochemical engineeringVirologyCell biologyChromatography methodsFiltration methodsCell culture technologiesMolecular biologyUpstream processingAseptic processingAnalytical assaysAKTAs softwareUNICORN softwareEntrepreneurial experienceTechnical support experienceDetail-orientedTeam collaboration

Required

BS or MS in biological engineering

2-8+ years of relevant industry experience

Solid foundation in the fundamentals of biochemical engineering, virology and cell biology

Experience with industry standard chromatography and filtration methods

Ability to hypothesize and drive key experiments for internal and external programs

Entrepreneurial experience dealing with customers in product development

Working knowledge of AKTAs and UNICORN software

Adaptability required as work schedule may change based on business needs

Criminal background check required

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

Preferred

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

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

Understanding of analytical assays used in the characterization of biologics

Familiar with tangential flow filtration skids

Ability to interface successfully with multi-disciplined teams

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