Senior Process Development Engineer

About the Company

Metric Bio are partnering with a global API CDMO on a search for a Sr. Process Development Engineer.

Responsibilities

• The ability to interact with chemists to help guide the development of new chemical processes, translate these processes into executable instructions, and guide operators through production.
• Provide guidance in scaling up production processes from the lab to the pilot plant.
• Be able to provide flexible solutions when processes do not scale as expected and be able to work closely with production operators in providing instructions.
• Able to assist other engineers with difficult scale up situations.
• Provide supporting documentations (batch records, specifications, hazard sheets, safety review packages, air emissions, processing reports) necessary to support processing in the plant.
• Conduct safety meetings, oversee execution of processing, participate on the floor as appropriate and review executed batch records.
• Interact closely with our chemistry and quality departments throughout the production process.
• External interactions include meeting with clients, vendors and contractors.
• Engineering support of pilot plant infrastructure.

Preferred Skills

• Proven success supporting first-time process scale-up, including pilot plant and kilo-scale operations.
• Hands-on experience with pilot plant infrastructure, process equipment, and facility interfaces.
• Strong problem-solving and troubleshooting ability, with demonstrated results in prior roles.
• Knowledgeable in process validation, cleaning validation, commissioning, and qualification activities.
• Effective communicator with excellent written and verbal skills for external collaboration and cross-functional engagement.
• Works productively within multi-disciplinary teams, building alignment across technical, operations, and quality groups.
• Highly motivated, proactive, and accountable with a track record of delivering against project objectives.

Qualifications

• B.S. or M.S. in Chemical Engineering or Chemistry with ten or more years of experience in scale-up/preparation of pharmaceutical and specialty chemicals.