Sr). Scientist, Upstream Process Development

(Sr). Scientist, Upstream Process Development

Pennington, NJ

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Pro Bio provides end-to-end CDMO services from drug discovery to commercialization with a focus on cell and gene therapy, vaccine, biologics discovery and antibody protein drugs. This role reports to the Senior Manager, Upstream Viral Vector Process Development & MSAT and is suited for a 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 opportunity to develop and expand technical expertise in viral vector manufacturing while contributing to gene and cell therapies. The role combines hands-on laboratory work with strategic process development and cross-functional collaboration.

• 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.

• Bachelor’s degree with 5-7 years, or Master’s Degree with 3-7 years, or Ph.D. with 0-3 years in Biology, Biochemistry, Chemical Engineering or equivalent with 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 a cGMP manufacturing environment.
• Familiarization with analytical methods for viral vector characterization (qPCR, ELISA, HPLC).
• Familiarization with 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.

The salary range, dependent upon experience level, is $80,000 - $110,000 annually.

GenScript USA Inc/Pro Bio Inc. is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.