Senior Manufacturing Engineer/Manufacturing Engineer

Celldex Therapeutics; Fall River (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in the biotech field is seeking a Senior Manufacturing Engineer to lead their GMP manufacturing team in Fall River. The role involves overseeing technical aspects, budget management, and continuous improvement initiatives. Ideal candidates will have extensive experience in biotech manufacturing and strong leadership skills.

Qualifications

• 8-10 years of biotech/biopharmaceutical experience for Senior role.
• Experience leading GMP manufacturing teams.

Responsibilities

• Lead the upstream and downstream GMP manufacturing team.
• Coordinate with Process Development and Manufacturing teams.
• Support development and optimization of new process technologies.

Skills

Leadership

Communication

Organizational Skills

Creativity

Flexibility

Education

B.S./M.S. in Biology

Biochemical Engineering

Chemical Engineering

Tools

Unicorn Software

DeltaV Software

MS Office Suite

Job description

Senior Manufacturing Engineer/Manufacturing Engineer

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Job Overview

The engineer will be responsible for leading the upstream and downstream GMP manufacturing team at our Fall River location and supporting continuous improvement efforts to ensure reliability, efficiency, and staff development.

Responsibilities

1. Lead the technical aspects of the upstream and downstream GMP manufacturing team at Celldex.
2. Assist in developing and managing budgets, schedules, and performance standards.
3. Coordinate regularly with Process Development, Assay Development, and Manufacturing teams.
4. Support development, optimization, and assessment of new process technologies, including scale-up and transfer from PD to Manufacturing.
5. Serve as liaison with external vendors for procurement of services and materials.
6. Support manufacturing operators during processing as needed.

Qualifications

1. B.S./M.S. in Biology, Biochemical Engineering, Chemical Engineering, or related field, or equivalent experience.
2. 8-10 years of biotech/biopharmaceutical experience for Senior Manufacturing Engineer; 4-8 years for Manufacturing Engineer.
3. Experience leading GMP manufacturing teams and supporting continuous improvement.
4. Proficiency in downstream processing of therapeutic proteins, chromatography (with Unicorn software), viral clearance/inactivation, filtration, and formulation.
5. Experience with upstream cell culture and single-use bioreactors, DeltaV software is a plus.
6. Strong skills in writing and implementing batch records and SOPs in a cGMP environment.
7. Ability to work independently and collaboratively, demonstrating creativity and flexibility.
8. Good understanding of experimental design, data analysis, report writing, and technical presentations.
9. Excellent communication and organizational skills.
10. Proficiency in MS Office Suite.

Celldex is an equal opportunity employer committed to diversity, equity, and inclusion.

Additional Information

• Seniority Level: Mid-Senior level
• Employment Type: Full-time
• Job Function: Engineering and Information Technology