Senior Manager, Biologics Manufacturing Technical Support

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

Benefits offered by this job

401(k) plan

Health care benefits

Paid holidays and vacation

Sick days

Job summary

Celldex Therapeutics, Inc. is seeking a Senior Manager Biologics Manufacturing Technical Support to lead tech transfer and provide manufacturing support across CDMOs, PV/CPV, and investigations.

You will collaborate with manufacturing sciences, operations, QA, and analytics to ensure compliant, scalable biologics production. The role requires 6+ years in biotech manufacturing, CDMO experience, and travel up to 30%.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Chemistry, Microbiology, or related discipline; advanced degree a plus.
• 6+ years of progressive experience in biotechnology/pharmaceutical/biologics manufacturing.
• 3+ years with biologics CDMOs and late-stage biologics programs.
• Strong data-driven decision making and cross-functional communication.
• Ability to travel ~30% of the time.

Responsibilities

• Lead technology transfer, scale-up, risk assessment, and CDMO coordination.
• Oversee CDMO batch data and manufacturing investigations (OOS/OOT) with CAPA.
• Act as person-in-plant to monitor upstream/downstream operations and review records.
• Lead process validation and CPV programs for commercial biologics.
• Collaborate with MSTE, QA, analytics, and operations to support tech-transfer and development.

Skills

CDMO management

Late-stage biologics

Data-driven decisions

Interpersonal skills

Travel 30%

JMP/Minitab

MS Office/Visio

Biotech manufacturing

Education

Bachelor's degree or higher

Tools

JMP/Minitab

MS Office

Visio

Job description

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

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.