Operations Lead; Shop Floor Supervisor

The Modality Agnostic Chemistry Scaleup (MACS) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides pilot plant operations experience and a strong understanding of engineering fundamentals.

• Serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center.
• Support an operations team member from testing and startup through to when the MACS facility is fully operational.
• Potentially support other new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network.
• Contribute to equipment and facility design, system commissioning/qualification, as well as other critical activity work streams to enable facility startup.
• Supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements to meet MACS objectives and customer requirements.
• Prioritize and assign daily activities for the operations staff.
• Implement process improvement actions to meet S&E (Safety & Environmental) and GMP requirements.
• Ensure facility readiness for API (Active Pharmaceutical Ingredient) processing and share accountability for the facility’s performance.
• Work cooperatively with MACS leadership team and cross-functional partners to drive overall success and performance of the building.

• Small Scale Organics Pilot Plant (SSO):
  The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites.
• Prep Lab Area:
  The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space.

• Bachelor’s degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment. — OR— High school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.

• Mechanical aptitude and familiarity with chemical process development and process equipment.
• Supervising a team of shop floor personnel in an operations environment.
• Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.
• Experience operating/maintaining manufacturing scale, pilot scale, and/or lab scale equipment.
• Effective communication skills and a collaborative mindset.
• Experience in conflict resolution and root cause analyses.
• Ability to build effective work relationships with a varied workforce.
• Adaptable to a dynamic production environment.
• Relevant experience in a process…