Company Overview: A pioneering biotechnology start-up specializing in immunotherapy. The company's mission is to reprogram the immune system to restore balance and address cancer and autoimmune diseases.
Position Overview: Seeking a proactive and innovative CMC Project Manager to lead the management of Chemistry, Manufacturing, and Controls (CMC) projects for small molecules and biologics, from early development through commercialization.
Responsibilities:
- Oversee and drive CMC project management for both drug substance and drug product.
- Collaborate with Clinical Development, Research and Development teams, and external consultants.
- Create and maintain project documentation including meeting minutes, presentations, action trackers, and budgets.
- Manage Third Party Manufacturers (CDMOs) deliverables and budgets.
- Identify and address issues, implementing mitigation plans as necessary.
- Develop and update CMC project plans and dashboards to achieve project goals.
- Solve complex problems and remove barriers to ensure timely project deliverables.
- Assess the impact of project changes on timelines, budgets, and resources.
- Document and communicate strategic and tactical decisions clearly.
Qualifications:
- 5+ years of experience in CMC project operations within a pharmaceutical or biopharma environment.
- Bachelor’s degree in science, engineering, or a health-related field required.
Knowledge/Skills:
- Strong project management, facilitation, and collaboration skills.
- Comprehensive understanding of small molecule and biologics development and manufacturing.
- Experience with CMC filing requirements in Europe or the US.
