GeneCoda has been engaged to identify and evaluate candidates, for a CMC Manufacturing Lead located in the RTP, NC marketplace.
About Our Client:
Our client is an immuno-oncology company developing novel therapies that activate a patient’s immune system to fight cancer.
Our client is filing several IND’s to advance multiple products into early phase clinical programs within the next year prompting the recruitment of this opportunity.
The CMC Manufacturing Lead will work closely with the 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.
- 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 CMO’s and provide technical oversight during manufacturing campaigns.
- Work collaboratively with CMOs, Quality Assurance, and Quality Control to ensure timely manufacturing and release of GMP compliant material.
- Coordinate manufacturing troubleshooting, 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 IND’s and regulatory submissions.
- Communicate project status updates and actions required to internal team members clearly and accurately.
- Monitor project costs to maintain the budget for the CMC group.
- Assist the Clinical Operations group as necessary to ensure continuity of material availability for use in supporting ongoing clinical trials.
Education: Bachelor of Science degree in chemistry, biology or related field. MS preferred.
- The CMC Manufacturing Lead will have extensive experience and knowledge in the development and manufacturing of clinical and commercial biological products.
- The CMC Manufacturing Lead will have a 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).
- 5+ years of biotechnology and/or pharmaceutical process development and/or CMC manufacturing work experience.
- 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.
- Prior CMO/CDMO interface and management experience.
- Biologics industry experience preferred.
- Passion for problem solving and teamwork.
- Strong collaborative skills, team player mentality.
- Effective decision-making and problem-solving
- Strong organizational skills.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
- Willingness to travel up to 10% of the time as work requires.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.