Associate Director, External Drug Product Manufacturing

About the role

Celldex is looking for an Associate Director, External Drug Product Manufacturing in Hampton, NJ. The role oversees ongoing and new drug product aseptic filling demands at Contract Manufacturing Organizations (CMOs) and manages the related budget, while following Good Manufacturing Practices, company policies and procedures. It supports the CMO by providing oversight of aseptic drug product manufacturing.

Key responsibilities

• Act as person-in-plant (PIP) for drug product fills at CMOs.
• Lead CMOs by providing forecasts and requesting quotations for drug product manufacturing operations.
• Liaise with clinical and commercial teams to create product forecasts.
• Investigate and onboard new drug product manufacturing CMOs.
• Review and approve invoices, and review master and executed batch records.
• Review excursions or deviations during shipment, handling and storage of drug products, drive investigations to resolution with Quality, CDMO and clinical sites, and implement procedures to prevent recurrence.

Required profile

• Bachelor's or Master's degree in Engineering or Biological Sciences.
• 5-8 years of experience managing aseptic drug filling operations at CMOs or in-house.
• Experience managing internal resources and external contractors and vendors.
• Knowledge of secondary packaging operations and of biopharmaceutical quality standards, validation guidelines and regulatory compliance.
• Strong experience writing and implementing batch records and SOPs in a cGMP environment.
• Ability to work on long-term planning and capital requests; 10-20% domestic and international travel required.

Required skills

• Project management skills and certification.
• Analyzing inventory, forecasts and budget spreadsheets.
• Proficiency in MS Outlook, Word, Excel, PowerPoint and Project.
• High-level competence in aseptic biopharmaceutical manufacturing of vials and pre-filled syringes.

What we offer

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