Associate Director, Drug Substance

About the role

Celldex, a biotechnology company developing antibody-based therapies for allergic, inflammatory and autoimmune disorders, is hiring an Associate Director, Drug Substance in Hampton, NJ. The role works cross-functionally with internal and external teams to support drug substance GMP external clinical and commercial manufacturing, process technology transfer, process validation and continuous process verification, and preparation of Module 3 of the CTD for commercialization of pipeline candidates.

Key responsibilities

• Support process characterization and validation for commercialization of pipeline drug candidates.
• Support GMP external manufacturing of clinical or commercial biologics drug substances.
• Review CDMO batch records, protocols and reports; lead or support troubleshooting, process risk analysis and manufacturing investigations.
• Serve as a person-in-plant to help manage CDMO activities.
• Lead technology transfer of pipeline candidates to external CDMOs.
• Support authoring Module 3 of the DS CTD for regulatory submissions.
• Support the Continuous Process Verification program for commercial biologics manufacturing.
• Work with analytical, formulation, quality assurance and regulatory teams on batch release, investigations, testing and stability programs.

Required profile

• Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Biological Sciences or a related field.
• 8+ years of progressive experience in biotechnology, pharmaceutical or biologics manufacturing.
• 3+ years managing or working with biologics CDMOs.
• 2+ years in late-phase biologics programs and 2+ years in CMC technical writing.
• Able to travel 10-15% of the time.

Required skills

• Good interpersonal skills for managing internal and external communications.
• Proficiency in MS Outlook, Word, Excel, Project, PowerPoint and Visio.

What we offer

• Expected base salary of $153,616 to $199,501.
• Annual discretionary bonus and long-term incentive.
• 401(k) with employer contribution, health care and other insurance for employee and family.
• Paid holidays, vacation and sick days.