(Sr). Scientist, Upstream Process Development

GenScript/ProBio • Pennington, NJ

99d

About The Position

The Scientist, Upstream Process Development & MSAT Department reports to the Senior Manager, Upstream Viral Vector Process Development & MSAT Department. This role is ideally suited for a dynamic, bench-focused individual to support and lead the translation of research processes to GMP-compliant manufacturing. The successful candidate will develop, scale-up, and evaluate the technology transfer of viral vector processes in a fast-paced biotechnology environment. This position offers an excellent opportunity to develop and expand technical expertise in viral vector manufacturing while contributing to life-changing gene and cell therapies. The role combines hands-on laboratory work with strategic process development and cross-functional collaboration.

Requirements

• Bachelor’s degree with 5-7 years, or Master’s Degree with 3-7 years, or Ph.D. degree with 0-3 years’ experience in Biology, Biochemistry, Chemical Engineering or equivalent with particular experience in gene and cell therapy product design.
• Experience with AAV and/or lentiviral vector production systems.
• Strong understanding of process scale-up, cGMP manufacturing technology transfer, and manufacturing support.
• Prior experience with cGMP manufacturing environment.
• Familiarization with analytical methods for viral vector characterization (qPCR, ELISA, HPLC).
• Familiarization of regulatory requirements for gene therapy products (FDA, EMA).
• Excellent organizational and project management abilities.
• Strong analytical and problem-solving skills with attention to detail.
• Strong interpersonal, verbal, and written communication skills.

Responsibilities

• Conduct hands-on experimental work in the development of upstream unit operations (cell culture, transfection, and harvest/clarification) for viral vector (AAV, LVV) manufacturing process.
• Design, execute, and analyze cell culture experiments using Design of Experiments (DOE) principles and report data summary packages.
• Collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies.
• Develop and optimize process parameters to improve yield, quality, and consistency of viral vector production with guidance.
• Independently follow detailed and comprehensive project timelines.
• Support/drive the start up of AAV/LVV lab operations including, but not limited to: Draft, review, and approval of Standard Operating Procedures (SOPs), Implementation of Lean 6 sigma/5s best practices, and streamlining material flow.
• Present updates to project or cross functional teams on process development and manufacturing support activities.
• Read and understand scientific literature in gene and cell therapy, use the knowledge to generate ideas and contribute to process design and development.
• Perform other duties as assigned based on business needs.

What This Job Offers

• Number of Employees: 5,001-10,000 employees