Senior Manager, Biologics Manufacturing Technical Support

Celldex Therapeutics, Inc.; Hampton (NJ); On-site; USD 134,000 - 173,000; Full time

Job summary

Celldex Therapeutics, Inc. is seeking a Senior Manager Biologics Manufacturing Technical Support to lead tech transfer, support manufacturing operations, and drive CPV and PV programs across internal teams and CDMOs.

You will review batch records, oversee investigations (OOS/OOT), and collaborate with manufacturing sciences, operations, analytics, and QA to ensure compliant, scalable biologics production. This role requires travel up to 30% and a strong data-driven mindset.

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree is a plus.
• 6+ years in biotech/pharma/biologics manufacturing.
• 3+ years with biologics CDMOs.
• 3+ years in late-phase biologics programs.
• Strong data-driven decision-making.
• Willingness to travel up to 30%.
• Excellent cross-functional communication.

Responsibilities

• Lead technology transfer, scale-up, risk assessment with CDMO.
• Track and analyze CDMO batch data; oversee investigations and CAPAs.
• Serve as PIP to monitor operations; review batch records/protocols/reports.
• Lead process validation for commercialization or CPV program.
• Collaborate with MSTOP, manufacturing operations, analytical and QA for tech-transfer and development.

Skills

Analytical thinking

Interpersonal skills

Travel readiness

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology

Tools

JMP

Minitab

MS Office

Visio

Job description

Overview

The Senior Manager Biologics Manufacturing Technical Support works cross-functionally with internal and external teams to lead technology transfer, provide manufacturing technical support, manage Contract Development Manufacturing Organization (CDMO) manufacturing deviations and investigations, process validation (PV), and continuous process verification (CPV) while adhering to Good Manufacturing Practices, company policies and procedures.

Responsibilities

• Lead technology transfer, scale-up, risk assessment, facility and process fit in partnership with CDMO.
• Track and analyze CDMO batch data using statistical tools, provide oversight as a technical expert for manufacturing investigations (OOS/OOT) and implementation of corrective actions.
• Serve as a person-in-plant (PIP) when required to monitor manufacturing (upstream/downstream processing) operations. Review manufacturing batch records, protocols, and reports.
• Lead process validation for commercialization of biologics drug substance or continuous Process Verification (CPV) program for commercial biologics manufacturing.
• Collaborate closely with internal and external cross-functional teams like manufacturing sciences and technology, manufacturing operations, analytical and quality assurance to support tech-transfer, scale-up, manufacturing investigations, process validation, and technology development.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline. Advanced degree is a plus.
• 6+ years of progressive experience within biotechnology, pharmaceutical, or biologics manufacturing environments.
• 3+ years of experience in managing or working with biologics CDMOs.
• 3+ years of experience in working with late-phase biologics programs
• Interpersonal skills to effectively manage internal and external communications.
• Strong scientific data-driven decision-making skills.
• Able to travel 30 % of time.
• Proficient in the use data analysis tools (JMP/ Minitab), MS office, Visio.

Compensation Statement

The expected base salary for this position is: $133579.00 to $173480.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page 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.