Operations Lead (Shop Floor Supervisor)

Responsibilities

• Serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center, a new potent, multi-modality drug substance development and GMP clinical manufacturing plant.
• Serve as a 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 SM PR&D network.
• Contribute to equipment and facility design, system commissioning/qualification, and other critical activity workstreams to enable facility startup.
• Supervise and participate in daily production activities while ensuring compliance with Safety, GMP Quality, and Environmental requirements.
• Prioritize and assign daily activities for the operations staff.
• Implement process improvement actions to meet S&E and GMP requirements.
• Ensure facility readiness for API processing and share accountability for the facility's performance.
• Work cooperatively with the MACS leadership team and cross-functional MACS partners to drive overall success and performance of the building.

Additional Supported Areas

As required and in addition to support of current capital projects, the Senior Specialist may provide direct support to other areas such as the Small Scale Organics Pilot Plant (SSO) and the Prep Lab Area.

Education Minimum Requirement

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.

Required Experience and Skills

• 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 cGMPs, GDPs, and 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 development lab or pilot plant/manufacturing facility.
• Must be able to rotate between 1st and 2nd shift on a weekly basis.
• Desire and willingness to learn, contribute and lead.
• Coordinating maintenance activities around processing activities to support reliable facility operation.
• Working in an environment with Automation Systems (DeltaV, PLC, etc.).

Desired Experience and Skills

• GMP facility design, equipment start-up and/or qualification.
• Small molecule drug substance and/or biologics process development.
• Supporting compliance investigations and change management.
• Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).
• Potent Compound processing and containment systems (e.g., isolators).
• Interacting with process utility systems associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
• Quality systems notifications, Root Cause Analysis (RCA), Corrective Action Preventative Action (CAPA), quality change controls, and/or safety Management of Change (MOC).