Senior Manufacturing Engineer/Manufacturing Engineer

Takeda Pharmaceutical Company Limited; Fall River (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading pharmaceutical company in Massachusetts is seeking a Manufacturing Engineer to lead upstream and downstream GMP manufacturing efforts. This role involves managing technical teams, improving processes, and ensuring efficient production while fostering staff development. The ideal candidate has extensive experience in biopharmaceutical manufacturing and strong leadership skills.

Qualifications

• 8-10 years of biotechnology/biopharmaceutical industrial experience for Sr. Manufacturing Engineer.
• Experience leading upstream and downstream GMP manufacturing teams.
• Skilled in downstream processing of therapeutic proteins.

Responsibilities

• Lead technical aspects of the upstream and downstream GMP manufacturing team.
• Assist in developing budgets, schedules, and performance requirements.
• Support the development and scale-up of new process technologies.

Skills

Chromatography

Viral clearance/inactivation

Filtration

Formulation

Data analysis

Technical presentations

Communication skills

Organizational skills

Education

B.S./M.S. in Biology, Biochemical Engineering, Chemical Engineering

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.
• 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 familiarity with experimental design.
• Ability to analyze data, prepare reports, and deliver technical presentations.
• Strong communication and organizational skills.
• Computer proficiency in Excel, Word, Project, and PowerPoint.