Process Engineer

Process Engineer

Location: St. Louis, MO

The Recombinant Mammalian DS Platform within the global MSAT (Manufacturing Science and Technology) team is responsible for the Life Cycle Management of mammalian cell culture-based drug substance processes within our biologics manufacturing network. Our mission is to deliver innovative, robust, and cost-effective processes to support the launch of new products and provide commercial manufacturing support. This team handles tech transfer activities, including process fit-gap assessments, process validation, dossier preparation, and PAI (Pre-Approval Inspection) support for launching new and lifecycle management products.

Our diverse portfolio includes 17 products across 5 modalities and 3 expression systems, spanning 12 internal and external global sites in the US and EU. We plan to support the launch of 20 new products over the next five years, including monoclonal and multi-specific antibodies, fusion proteins, and antibody-drug conjugates. Our recent initiatives have led to the establishment of second-generation manufacturing processes with continuous platforms, and we are actively pursuing innovations such as digital labs and advanced analytics for enhanced process understanding and control.

Key Responsibilities:

The successful candidate will collaborate with a team of scientists and engineers focused on supporting commercial mammalian cell culture processes within external manufacturing. Responsibilities may vary among individuals in similar roles and may evolve based on business needs.

• Provide technical support and conduct routine process monitoring for commercial products produced by Contract Manufacturing Organizations (CMOs).
• Perform in-plant observations of manufacturing operations at CMOs and communicate findings to the product team.
• Review and analyze manufacturing processes, deviations, and relevant data from development and production.
• Evaluate manufacturing batch records, protocols, and control strategies.
• Offer technical support and data analysis for investigations and resolution of deviations.
• Recommend changes or additional experiments aimed at improving quality, productivity, recovery, and overall efficiency.
• Collaborate with colleagues and external partners in Engineering, Manufacturing, and Quality departments.
• Oversee and report on the overall progress of manufacturing activities.

Basic Qualifications:

• Bachelor's degree in Engineering or Science with a minimum of 5 years of relevant experience,

OR

• Master's degree in Engineering or Science with a minimum of 3 years of relevant experience.
• Experience in biologics development, bioprocess engineering, technology transfer, and/or commercial manufacturing operations.

Preferred Qualifications:

• Familiarity with Good Manufacturing Practices (GMP) and experience in supporting a commercial facility.
• Experience in cell culture and/or downstream purification (direct lab experience is a plus).
• Knowledge of equipment qualification and process validation.
• Experience with formal root cause analysis and/or risk assessment.
• Proficiency in statistical analysis software and investigative data analysis.
• Experience leading projects and communicating effectively with cross-functional teams.
• Strong technical writing and verbal communication skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Special Working Conditions:

• Ability to gown and access manufacturing areas.
• Willingness to travel up to 20% of the time.