Senior Manufacturing Engineer/Manufacturing Engineer

Bimbo Bakeries USA, Inc.; Fall River (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in Fall River is looking for a Manufacturing Engineer to lead their GMP manufacturing team. The role involves overseeing the production processes, ensuring efficiency, and implementing improvements. Ideal candidates will have extensive experience in the biotechnology field, as well as strong skills in laboratory operations and team leadership.

Qualifications

• 8-10 years of biotechnology/biopharmaceutical experience for Sr. Manufacturing Engineer; 4-8 years for Manufacturing Engineer.
• Experience leading GMP teams.
• Skilled in writing and implementing batch records and SOPs.

Responsibilities

• Lead technical aspects of upstream and downstream GMP manufacturing.
• Develop budgets and performance requirements.
• Support development and optimization of new process technologies.

Skills

Downstream processing

Chromatography

Filtration

Formulation

Cell culture

Data analysis

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 the scale-up and technology transfer of processes 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 biotechnology/biopharmaceutical industrial experience for Sr. Manufacturing Engineer; 4-8 years for Manufacturing Engineer.
• Experience leading upstream and downstream GMP manufacturing teams and supporting continuous improvement efforts.
• 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, standard procedures, and limited supervision.
• Understanding of experimental design and data analysis.
• Strong communication and organizational skills.
• Proficiency with Excel, Word, Project, and PowerPoint.