Heat Biologics is a clinical-stage biopharmaceutical company and Pelican Therapeutics is a wholly-owned subsidiary of Heat. Together they are progressing a portfolio of immunotherapy products to fight cancer. In the next year, Heat/Pelican will have multiple products in numerous early phase clinical programs. The CMC Manufacturing Project Lead will work closely with the Heat/Pelican Research & Development and Analytical teams to implement manufacturing strategies to ensure product supply to support all clinical programs. This position will be responsible for technical oversight of all manufacturing activities at CMOs - leading process technology transfers, defining batch processes/documentation and direct review of all associated contract manufacturing activities. The Manufacturing Project Lead will also participate in the definition and execution of process validation activities needed in the preparation of applications for licensure. The ideal candidate will have extensive experience and knowledge in development and manufacturing of clinical and commercial biological products. They will have complete understanding of technology transfers and GMP manufacturing of clinical trial material and will have been directly involved in late stage process validation programs in preparation for licensure. This role is highly complex and applies knowledge of CMC development and broad manufacturing expertise (upstream/downstream process steps, drug substance and drug product). This position will be based in Durham, North Carolina and the successful candidate must be organized, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.
- Interact/communicate with contract manufacturing and analytical laboratory organizations to coordinate process development, assay development and activities for CMC manufacturing programs.
- Manage and lead Process Technology Transfer activities at CMOs and provide technical oversight during manufacturing campaigns.
- Work collaboratively with CMOs, Heat Quality Assurance and Quality Control to ensure timely manufacturing and release of GMP compliant material.
- Coordinate manufacturing trouble shooting, investigations, root cause analysis, CAPAs, impact assessment and change controls.
- Author and/or review manufacturing documentation (e.g. Protocols, Process Description, Batch Records, SOPs, Change Controls, etc.).
- Contribute to the writing and review of INDs and regulatory submissions.
- Communicate project status updates and actions required to internal team members clearly and accurately.
- Monitor project costs to maintain budget for the CMC group.
- Assist Clinical Operations group as necessary to ensure continuity of material availability for use in supporting ongoing clinical trials.
- Perform other duties as assigned.
- BA/BS degree; MS preferred in scientific discipline.
- 5+ years of biopharma process development and/or CMC manufacturing work experience.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Strong knowledge of GMP/GLP manufacturing and laboratory environments/requirements and familiarity with clinical trial packaging/labeling and distribution.
- Firm understanding of manufacturing quality systems and industry practices
- Strong cross-functional interpersonal skills.
- Excellent oral and written communication and attention to detail.
- Proficiency in MS Office suite, including Word, Excel, and PowerPoint.
- Ability to travel up to 10% as needed.