Senior Manufacturing Engineer/Manufacturing Engineer

Quality Control Specialist - Pest Control; Fall River (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A biotechnology company is seeking a Manufacturing Engineer in Fall River. The role involves leading the GMP manufacturing team, optimizing processes, and developing budgets. Candidates should have a B.S./M.S. in relevant fields and 4-10 years of industry experience, alongside strong leadership and communication skills.

Qualifications

• 8-10 years of biotechnology/biopharmaceutical industry experience for Sr. Manufacturing Engineer.
• 4-8 years for Manufacturing Engineer.
• Experience leading GMP manufacturing teams.

Responsibilities

• Lead upstream and downstream GMP manufacturing team.
• Assist in developing budgets and performance metrics.
• Collaborate with Process and Assay Development teams.

Skills

Communication

Organization

Data Analysis

Experimental Design

Technical Presentations

Leadership

Education

B.S./M.S. in Biology

B.S./M.S. in Biochemical Engineering

B.S./M.S. in 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 managing budgets, schedules, and performance metrics.
• Collaborate regularly with Process Development, Assay Development, and Manufacturing teams.
• Support the development, optimization, and assessment of new process technologies, including scale-up and technology transfer from PD to Manufacturing.
• Serve 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 biotechnology/biopharmaceutical industry experience for Sr. Manufacturing Engineer; 4-8 years for Manufacturing Engineer.
• Experience leading upstream and downstream GMP manufacturing teams and supporting continuous improvement to ensure 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 ability to work with limited supervision, based on previous experience and standard procedures.
• Strong understanding of experimental design.
• Ability to analyze data, prepare reports, and deliver technical presentations.
• Excellent communication and organizational skills.
• Proficiency in computer skills including Excel, Word, Project, and PowerPoint.