Address
Form of workOverview
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 to help build a commercial team from the ground up. The Associate Manager/ Manager Drug Substance works cross-functionally with internal and external teams to support Drug Substance (DS) GMP external manufacturing, process characterization and validation for commercialization of pipeline drug candidates while adhering to Good Manufacturing Practices, company policies and procedures.
Responsibilities
- Support Drug Substance (DS) GMP external manufacturing, process characterization and validation for commercialization of pipeline drug candidates.
- Review CDMO batch record, protocol, and reports. Lead/ support troubleshooting, process risk analysis and manufacturing investigations.
- Serve as a person-in-plant (PIP) to assist in management of CDMO activities.
- Support authoring and/ or review of CMC sections for regulatory submissions.
- Collaborate closely with internal and external cross-functional teams like analytical, formulation, quality assurance and regulatory to support batch release, manufacturing investigations, testing and stability programs.
Qualifications
- Interpersonal skills to effectively manage internal and external communications.
- Able to travel 10-15 % of time.
- Proficient in the use MS Outlook, Word, Excel, Project, PowerPoint, Visio.
Education/Experience:
- Master’s degree with 6+ years of experience in Chemical engineering or Biochemical engineering or Biochemistry or Biological Sciences.
- 2+ years of experience in managing biologics CDMOs.
- 1+ years of experience in managing late-phase biologics programs.
- Able to travel 10-15 % of time.
