Process Development Engineer

Provide technical support for drug product process development, including formulation, filtration, filling (vials/syringes/devices), and lyophilization of parenteral products.

Assist in the development and characterization of drug product processes and the transfer of new technologies to commercial sterile fill/finish sites.

Support process development for commercial drug product processing in areas such as sterile processing, process characterization, tech transfer, and validation.

Collaborate with manufacturing and support functions to provide coordinated support for commercial drug product manufacturing operations and technology transfer.

Participate in global cross-functional teams, working effectively in a highly matrixed team environment to drive efficiency and foster strong relationships.

Troubleshoot issues with drug product processing technologies and equipment, utilizing data-driven analyses and visualizations to determine true root causes.

Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory submissions.

• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field.
• 3+ years of drug product process development experience in the pharmaceuticals/biotechnology industry.
• Knowledge of and hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations.

Associate

Full-time

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