Process Engineer, MSAT

• 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.

• 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.

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

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