Senior Manager, Biologics Manufacturing Technical Support

About the role

Celldex, a biotechnology company developing antibody-based immunology therapies, is hiring a Senior Manager, Biologics Manufacturing Technical Support in Hampton, NJ. The role works cross-functionally with internal and external teams to lead technology transfer, provide manufacturing technical support, manage CDMO manufacturing deviations and investigations, and run process validation (PV) and continuous process verification (CPV) in line with Good Manufacturing Practices.

Key responsibilities

• Lead technology transfer, scale-up, risk assessment, facility and process fit with the CDMO.
• Track and analyze CDMO batch data with statistical tools, oversee manufacturing investigations (OOS/OOT) and corrective actions.
• Act as a person-in-plant when needed to monitor upstream and downstream manufacturing, and review batch records, protocols and reports.
• Lead process validation for commercial biologics drug substance or the CPV program for commercial biologics manufacturing.
• Work with manufacturing sciences and technology, manufacturing operations, analytical and quality assurance teams on tech transfer, scale-up, investigations, process validation and technology development.

Required profile

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology or a related field; advanced degree is a plus.
• 6+ years of progressive experience in biotechnology, pharmaceutical or biologics manufacturing.
• 3+ years managing or working with biologics CDMOs and 3+ years with late-phase biologics programs.
• Able to travel 30% of the time.

Required skills

• Data analysis tools such as JMP and Minitab.
• MS Office and Visio.
• Scientific, data-driven decision-making and strong communication with internal and external stakeholders.

What we offer

• Expected base salary of $133,579 to $173,480.
• 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.