Process Engineer - Manufacturing Sciences and Technology

Position Summary:

This position will serve as a mid-level engineer focused on drug product and process development in the Manufacturing Sciences and Technology (MSAT) department. This engineer will join a team in the clinical and commercial development of the processes used to manufacture sustained release hydrogel drug products. This role includes but is not limited to experimental design, process development, packaging, inspection and material characterization. This individual will execute some assigned project activities, lead some project activities, and work with team members to improve, evaluate, and develop the products and their associated processes. This engineer will be supporting the integration of a drug product with a medical device to produce a combination product. The position is set in a dynamic and fast-paced environment at a growing company.

Critical areas of focus will be in experimental design, laboratory work, testing, technical transfers, scale-up and new process development. Incorporation of automation into a complex manual process will be another area of focus for this engineer. This position will be based full-time onsite in Bedford, MA.

Principal Duties and Responsibilities:

• Design, develop, execute and characterize process development studies.
• Design and develop unit operations of a scalable commercial manufacturing process.
• Execute improvement of current clinical and commercial manufacturing activities.
• Implement and integrate automated systems into a complex manual process.
• Assist in the cGMP manufacturing of drug product batches in clean room environment to support clinical studies.
• Understand GMP regulation and FDA/EMEA guidance on manufacturing processes and apply them during manufacturing of combination product batches.
• Analyze and evaluate the impact of process variables on combination product characteristics.
• Communicate study designs, data analysis and conclusions to project team members.
• Generate technical documents including protocols and reports summarizing experimental plans and test results.
• Collaborate effectively with MSAT group and project team members.
• Serve as an MSAT SME in cross-functional interactions with other departments.
• Demonstrate an understanding of late-stage combination product development and tech transfer needs of commercial development.

Requirements:

• Minimum of a bachelor’s degree (advanced degree desirable) in Chemical Engineering, Biomedical Engineering, Mechanical Engineering or related discipline.
• 4+ years of biopharma industry experience in drug or combination process development.
• Prior experience working within a cGMP manufacturing environment.
• Ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
• Experience creating technical, written content.
• Demonstrated written and verbal communication skills.
• Demonstrated data analysis and problem-solving skills.
• High degree of initiative and self-motivation.
• A diligent team-player that is passionate about helping patients and effectively collaborates in a dynamic, cross-functional environment.
• Experience with generic lab equipment (Ex. pipettes, balances, pumps, microscopes) is preferred.
• Experience with automated or manual inspection systems is preferred.

Working Conditions:

• Production Floor – gowning/cGMP requirements.
• Laboratory/Clean Room – bending/lifting requirements.

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Salary Range 94000 - 125000 USD