Scientist II/III - Upstream Process Development

Genezen; Indianapolis (IN); On-site; USD 168,000 - 295,000; Full time

Job summary

Genezen, a leading company in gene therapy, is seeking a Scientist II/III specializing in Upstream Process Development. This role involves developing scalable viral vector production processes, ensuring compliance and quality, and collaborating with various stakeholders. An ideal candidate will have significant experience in biochemical engineering, virology, and process optimization.

Benefits

Paid vacation

Sick time

Holidays

401(k) with company match

Healthcare plans

Dental and vision care

Insurance options

Qualifications

• 5-8 years of relevant industry experience required.
• Solid foundation in biochemical engineering and experience in the pharmaceutical industry preferred.
• Experience in upstream processing and regulatory compliance.

Responsibilities

• Direct development of scalable viral vector production processes.
• Monitor process performance and implement improvements.
• Design and execute independent experiments and manage compliance.

Skills

Biochemical Engineering

Virology

Cell Biology

Cell Culture Technologies

Molecular Biology

Aseptic Processing

Education

BS, MS, or PhD in Biological Engineering

Job description

Scientist II/III - Upstream Process Development

Scientist II/III - Upstream Process Development

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The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. The Scientist II/III in Upstream Process Development will direct the development and establishment of processes in Process Development. This individual is accountable for developing a scalable platform for viral vector production processes that minimizes the risk during Process Development to GMP scale-up. The individual will provide technical expertise and leadership in science & technology and requires close collaboration with internal stakeholders. Essential job functions include establishing the platform from small scale through intermediate scale (50L) lentiviral and retroviral vector processes, monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality. The role involves developing and supporting process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity. The candidate will design and execute experiments independently, maintain open communication, stay current with relevant technologies, perform and lead single-use system design manifold, selection, implementation, configurations in upstream bioreactor and downstream unit operations, develop proper SOP/SSP for upstream processes, manage process transfer from or to clients and in-house manufacturing, maintain external technical relationships, serve as process SME for regulatory and client audits, and ensure compliance with OSHA, EHS, Quality, and cGMP procedures. The position requires adaptability, a criminal background check, and other duties as assigned. Education requirements include BS, MS, or PhD in biological engineering with 5-8 years of relevant industry experience. Desired skills include a solid foundation in biochemical engineering, virology, cell biology, entrepreneurial experience, pharmaceutical industry experience, and knowledge of cell culture technologies, molecular biology, upstream processing, and aseptic processing. Physical demands include working in a BSL 2 environment, exposure to machinery and chemicals, and frequent physical activity. Genezen values scientific commitment, urgency for patients, resilience, excellence, integrity, and solution-driven partnership. Benefits include paid vacation, sick time, holidays, 401(k) with company match, healthcare plans, dental and vision care, and insurance options. The position is based in Fishers, Indiana, a suburb of Indianapolis, or Lexington, Massachusetts. Genezen is an Equal Opportunity Employer and participates in EVerify. Visa sponsorship is not available.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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