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Scientist II, Upstream Process Development jobs in United States
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Genezen · 3 months ago

Scientist II, Upstream Process Development

Genezen is a company focused on gene therapy, providing process development and GMP viral vector production for clinical trials. The Scientist II will direct the development of processes in Upstream Process Development, ensuring scalable viral vector production and collaborating closely with internal stakeholders.
BiotechnologyManufacturingLife ScienceGenetics
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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

Upstream process developmentCell culture technologiesCGMP manufacturingBiochemical engineeringMolecular biologyAseptic processingBioreactor operationsTechnical supportProcess designTeam collaborationDetail-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
Solid foundation in the fundamentals of biochemical engineering, virology and cell biology
Working knowledge of Upstream process (Cell culture, Aseptic Technique, bioreactor operations)
Ability to interface successfully with multi-disciplined teams
Extremely detail-oriented with strong technical skills & mechanically inclined/knowledge of hand tools

Preferred

Entrepreneurial experience dealing with customers in product development
Hands-on experience on complex biologics e.g. gene therapy, transient transfection, baculovirus infection
Working knowledge of Upstream process (process design and bioreactor scale up, cGMP manufacturing)

Benefits

Paid vacation days, amount based on tenure
Paid sick time
10 observed holidays + 2 floating holiday + 1 volunteer day
401(k) plan with company match up to 6% of salary, vested immediately
Share Appreciation Rights
Choice of several healthcare plans
FSA and HSA programs
Dental & vision care
Employer-paid basic term life/personal accident insurance
Voluntary disability, universal life/personal accident insurance
Accidental Death & Dismemberment (AD&D) Insurance

Company

Genezen

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Genezen offers contract process development, GMP viral vector production, transduced cell manufacturing, and testing services.

Funding

Current Stage
Growth Stage
Total Funding
$18.5M
Key Investors
Ampersand Capital Partners
2023-11-02Series Unknown· $18.5M

Leadership Team

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Steven J. Favaloro
Chairman & CEO
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Michael Wourms
Chief Operations Officer
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Company data provided by crunchbase