Senior Manufacturing Engineer/Manufacturing Engineer

Celldex Therapeutics, Inc.; Fall River (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading biopharmaceutical company in Fall River seeks a Manufacturing Engineer to lead upstream and downstream GMP manufacturing efforts. The role involves optimizing processes, managing budgets, and collaborating with various teams to enhance efficiency and reliability. Ideal candidates will have extensive experience in biotech and strong leadership skills.

Qualifications

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

Responsibilities

• Lead the GMP manufacturing team at Fall River.
• Support development and optimization of new process technologies.
• Act as a liaison for procurement of services and materials.

Skills

Leadership

Communication

Organizational Skills

Education

B.S./M.S. in Biology

Biochemical Engineering

Chemical Engineering

Tools

Unicorn Software

Excel

Word

Project

PowerPoint

Job description

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

• Lead the technical aspects of the upstream and downstream GMP manufacturing team at Celldex.
• Assist in developing and administering budgets, schedules, and performance requirements.
• Interact regularly with Process Development, Assay Development, and Manufacturing teams.
• Support the development, optimization, and assessment of new process technologies, as well as scale-up and technology transfer from PD to Manufacturing.
• Act as a liaison with external parties regarding procurement of services and materials for products manufactured at the Fall River site.
• Support manufacturing operators during processing as needed.

Qualifications

• B.S./M.S. in Biology, Biochemical Engineering, Chemical Engineering, or equivalent experience.
• 8-10 years of biotech/biopharmaceutical industrial experience for Sr. Manufacturing Engineer; 4-8 years for Manufacturing Engineer.
• Experience leading upstream and downstream GMP manufacturing teams, supporting reliability, efficiency, and staff development.
• Skilled in downstream processing of therapeutic proteins, including chromatography (using Unicorn software), viral clearance/inactivation, filtration, and formulation.
• Experience with upstream cell culture and single-use bioreactors; DeltaV experience is a plus.
• Proficient in writing and implementing batch records and SOPs in a cGMP environment.
• Ability to work independently and collaboratively with creativity and flexibility.
• Good judgment and experience working with limited supervision.
• Understanding of experimental design.
• Ability to analyze data, prepare reports, and deliver technical presentations.
• Strong communication and organizational skills.
• Proficient in Excel, Word, Project, and PowerPoint.

Celldex is proud to be an equal opportunity employer committed to diversity, equity, and inclusion through development, recruiting, and community outreach.