Senior Manager, Biologics Manufacturing Technical Support

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

Benefits offered by this job

401K plan

Health care

Paid holidays

Vacation and sick days

Long term incentive

Job summary

The Senior Manager Biologics Manufacturing Technical Support at Celldex leads cross-functional tech transfer, supports manufacturing, and oversees CDMO deviations and investigations, PV and CPV, while ensuring GMP compliance.

Partnering with manufacturing sciences, operations, analytics and QA, you will review batch records, lead scale-up, risk assessments, and CPV/PV activities in collaboration with internal teams and external CDMOs; travel up to 30% is required.

Qualifications

• The candidate will have 6+ years in biotech/pharma manufacturing environments.
• Experience with biologics CDMOs a plus and late-phase programs.
• Strong data-driven decision making and cross-functional communication.

Responsibilities

• Lead technology transfer, scale-up, risk assessment, facility and process fit with CDMO.
• Track and analyze CDMO batch data; oversee investigations (OOS/OOT) and CAPA.
• Serve as person-in-plant to monitor upstream/downstream ops; review batch records, protocols, and reports.
• Lead process validation for commercialization or CPV programs for biologics.

Skills

Tech transfer leadership

Scale-up expertise

Risk assessment

Cross-functional collaboration

Data-driven decision making

Process validation

CPV program

Travel readiness

Education

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

Advanced degree is a plus

Tools

JMP

Minitab

MS Office

Visio

Job description

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.