Scientist II, Process Development & MSAT
| Company | CG Oncology |
|---|---|
| Location | Massachusetts, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s Degree in science (e.g., chemistry, biotechnology, pharmaceutical sciences, or related discipline)
- Five (5) years of relevant experience in pharmaceutical/biotechnology industry experience in managing CDMOs for the manufacture of non GMP and cGMP DS and DP
- Experience with projects clinical through Phase 3, BLA including multiple molecule types (cell and gene therapy experience a plus)
- Good knowledge of cGMP manufacturing and filings; thorough and relevant knowledge of FDA and EMA regulations
- Project skills in identifying and resolving critical issues
- Able to work effectively with senior management
- Demonstrated experience in working on site and remotely at a CDMO
Responsibilities
- Provide technical support to the transfer team(s) responsible for end-to-end transfer of knowledge, process and technology developed by the CGO technical teams for vector product manufacturing to CGO chosen manufacturing sites.
- Assist in troubleshooting manufacturing issues at contract & strategic partners. In collaboration with Technical Operations partners (manufacturing, quality, supply, project management, etc.), ensure timely support for tech transfer, product/process investigations, training, and improvement projects.
- Support Tech Ops team in Developing 2nd generation drug substance processes targeting reduced COGs and improved manufacturability, timelines, and development plans in collaboration with broader global team including project management, MS&T, QC, QA, and regulatory members.
- Assess and provide insight to the implementation of phase appropriate process development and optimization, manufacturing, and validation activities at external CDMOs by following the FDA guidance and QbD principles in accordance with documented work plans and cGMP requirements to ensure on time delivery of clinical trial materials (CTM).
- Reviews Draft, Master, and Executed Batch Records, protocols and reports related to all GMP operations related to the finished product.
- Provides technical guidance and communicates clearly and concisely across multiple business functions, building effective relations with internal and external partners.
- Participates in GMP investigations; develops corrective action plans and implements such plans to resolve process and product issues.
- Work collaboratively with Quality Assurance and Regulatory Affairs to ensure a high level of cGMP compliance.
- Assist in the technical aspects of the company’s regulatory filings, including process validation for the upcoming BLA filing.
Preferred Qualifications
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No preferred qualifications provided.