Job Description

Position Overview

The Process Sciences Scientist I role applies scientific expertise and cGMP manufacturing experience to the development, characterization, transfer, and production of gene therapy candidates. The successful candidate will contribute to the support of process development and characterization for the cGMP manufacture of recombinant gene therapy vectors, manage process development and analytical lab activities, and assist in the technical transfer to external manufacturing sites. This individual will collaborate with teams across Translational Sciences, R&D, Manufacturing, Analytical/QC, QA, and Regulatory Affairs to support clinical and commercial supply efforts, as well as interface with CDMOs and other external partners.

Key Responsibilities

• Contribute to the development and characterization of upstream and downstream processes using both bench-scale and larger single-use systems within Process Sciences laboratories. This includes hands-on lab work, protocol drafting and execution, data analysis, and reporting.
• Manage process and analytical laboratory operations, including inventory tracking, calibration/PM coordination, and preparation of analytical/reagent materials.
• Support technology transfer activities from R&D to cGMP manufacturing facilities, either internal or at CDMOs.
• Conduct data analysis from internal and CDMO development/characterization efforts and manufacturing batches.
• Assist with drafting process descriptions, study protocols, and development summary documentation.
• Review and approve batch records and PPQ study documentation generated by CDMOs.
• Provide person-in-plant (PIP) support and communicate manufacturing results and progress in a timely manner.
• Participate in troubleshooting activities related to cGMP investigations, including OOS and other deviations.

Qualifications & Requirements

• Ph.D. with 0–3 years of relevant experience, M.S. with 3–7 years, or B.S. with 7+ years.
• Practical experience in cGMP manufacturing, biotechnology, or the pharmaceutical industry, with demonstrated capabilities in process development, scale-up, and technology transfer.
• Strong understanding of bioprocessing with hands-on experience in executing protocols/SOPs and thorough documentation practices.
• Ability to manage multiple projects, meet deadlines, and work collaboratively within cross-functional teams.
• Proven track record in both early- and late-stage process development.
• Excellent communication skills, both written and verbal.
• Strong focus on quality, detail, and delivering patient-centric solutions.

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