Work Location: Middlesex County, Massachusetts

Summary:

Seeking a hands-on Manufacturing Lead to oversee and optimize drug product manufacturing operations, while supporting the rollout of SAP S/4HANA. This role bridges operations and digital transformation, ensuring manufacturing processes are designed, adopted, and sustained in routine operations.

Responsibilities:

• Lead the design, mapping, and optimization of manufacturing processes in collaboration with global process owners.
• Translate operational requirements into SAP S/4HANA configuration by working closely with Digital/IT teams.
• Validate master data and ensure compliance with GMP/GxP and data integrity standards in daily manufacturing execution.
• Oversee FIT–GAP analysis, testing, and user acceptance testing to ensure operational readiness and integration validation.
• Train operators, update SOPs, and provide hypercare support to ensure stable and compliant manufacturing operations during go-live and adoption phases.
• Track key performance indicators (safety, quality, delivery, cost) and drive continuous improvement initiatives.
• Collaborate with Quality, Supply Chain, Engineering, and IT teams to support effective manufacturing operations and align processes with global templates and site needs.
• Demonstrate strong shop-floor engagement, ownership of operational challenges, and a problem-solving mindset in a regulated manufacturing environment; perform other duties as assigned.

Qualifications:

• Bachelor’s degree in Pharmacy, Chemical Engineering, Industrial Engineering, or related field.
• 5+ years of experience in pharmaceutical or medical device manufacturing or relevant industry experience.
• Expertise in SAP PP/PI implementation.
• Strong understanding of GMP and regulatory requirements.
• Experience with MES, EBR, or LIMS as part of manufacturing operations.
• Project management experience.
• Lean/Six Sigma experience preferred.
• Regulatory exposure preferred.
• Ability to multitask, operate computer/office machines, and perform physical activities such as standing, walking, sitting, reaching, climbing, stooping, kneeling, crouching, crawling, talking, and hearing.
• Willingness to travel up to 20% of the time during the initial phase.

Published Category: Manufacturing & Technical Operations