Sr. Scientist, Upstream Process Development

Location - Cranbury, NJ (on-site)

General Summary
Our Client is seeking Associate/Scientists, Process Development (USPD), to provide technical expertise to develop viral production solutions in support of clinical
and commercial virotherapy products for our pharmaceutical customers.

In collaboration with the site downstream process developments (DSPD) and Bioanalytics Development (AD) and global cGMP manufacturing operation, and external partners, USPD team will be responsible for delivering on upstream process strategies and strategy implementations. The ideal candidate will have experience in the area of gene therapy and a subject matter expert in MCB/WCB, MVSS and viral production.

Key Responsibilities:

• Drive upstream process developments, e.g., MCB/WCB, MVSS and viral production
• Drive innovation and continuous improvement with process equipment, automation technology and platforms with USP viral vector production, such as AAVs, Lentivirus, OVs, etc.
• Develop upstream manufacturing processes to meet individual customers’ needs for their pre-clinical, clinical and/or commercial gene therapy.
• Excellent in process characterization and optimization to assure process reliability and robustness in preparation for comparability and process validation. Participate in evaluation of new technology, raw materials qualification and process automation for introduction into GMP manufacturing.
• Ensue team collaborates with internal stakeholders and external vendors and suppliers to support materials changes, secondary source qualification and define requirements and understand functional specifications
• Participate and report to a cross-functional development team to advance production activities
• Ensure project executions in a timely matter and meet quality expectations.

Qualifications:

• B.S./M.S./PhD Degree in Biochemical Engineering, Biotechnology, molecular biology or genomics; pharmaceutical manufacturing & process development experience will be a PLUS.
• Hand-on expertise in viral production upstream process developments, cell culture (e.g., HEK293, SF9, etc.), adherent/suspension system, bioreactor optimizations across different platforms.
• Demonstrated knowledge and preferred expertise in cell line development or MCB/WCB, virus production, e.g., AAVs, Lentivirus, OVs.
• Previous experience with gene/cell therapy products or viral product is highly recommended.
• Previous experience with CRISPR gene editing, viral engineering and/or viral production system innovation is a plus.
• Ability to think critically, and demonstrated troubleshooting and problem solving skills
• Ability to function efficiently and independently in a changing environment
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Understands and employs principles and concepts of QbD and CMC regulatory documentation is a plus.