Celldex is a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Celldex has validated pipeline programs, an experienced management team who pioneered early antibody technologies, and support from leading healthcare investors. At Celldex, you’ll work with some of the industry’s most talented scientists and business professionals in a meaningful, inclusive, and exciting work environment.
The Senior Manager/ Associate Director CMC Project Manager will support a cross-functional internal and external teams to support Celldex’s pipeline and to prepare for commercialization of late-stage candidates while adhering to Good Manufacturing Practices, company policies and procedures.
Responsibilities
- Map the CMC strategy and communicate priorities
- Support Celldex products CMC Timelines and Deliverables
- Map and support overall CMC Drug Substance (DS) and Drug Product (DP) timelines from internal and external activities.
- Track action items, critical path items and key deliverable to maintain Celldex products on track.
- Track contracts, budgets, invoices, trend PO coverages, and generate cost analysis.
- Support and track product timelines and deliverables for the CDMO activities and execution of Process Qualification batches for both DS and DP.
- Prepare CMC commercialization plans to support Celldex product launch.
Qualifications
- Bachelor’s degree in engineering or Biological Sciences required. Master’s degree preferred.
- 5+ years of experience in biotech or pharmaceutical industry with 1-3 years of Biologics development or manufacturing experience
- A minimum of 3 years’ experience as a Project Manager in a biopharmaceutical company
- Experience with supporting BLA submissions. Product launch experience is a plus.
- Interpersonal skills to effectively manage internal and external communications.
- Able to travel 5-10% of time.
- Proficient in the use of MS Project and other project management tools
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.