Job Summary
Hands-on Manufacturing Lead to own and optimize drug product manufacturing operations at our Billerica formulation plant, while supporting the SAP S/4HANA rollout. This role bridges Operations and Digital Transformation, ensuring that manufacturing processes drive system design, adopted by the shop floor, and sustained in routine operations.
Area Of Responsibility
• Process Design & Operational Enablement:
- Lead design, mapping, and optimization of manufacturing processes in consultation with global process owners
- Work with Digital/IT to translate operational requirements into SAP S/4HANA configuration
- Validate master data from an operations and GMP perspective
- Ensure GMP/GxP and data integrity compliance in daily manufacturing execution
• Implementation & Testing:
- Lead FIT–GAP, testing, UAT to ensure operational readiness and continuity of manufacturing execution and integration validation
• Go-Live & Adoption:
- Train operators, update SOPs, support hypercare to ensure stable and compliant manufacturing operations
• Continuous Improvement:
- Track KPIs (safety, quality, delivery, cost), and drive continuous improvement initiatives.
• Cross-Functional Collaboration:
- Liaise with Quality, Supply Chain, Engineering, IT to support effective manufacturing operations
- Liaise with the central operations team for alignment of the process with SUN global template and site operational needs
• Behavioral Expectations
- Strong shop-floor engagement and ownership of day-to-day operational challenges
- Problem-solving mindset in a regulated manufacturing environment
• Other Duties as assigned
Work Conditions:
• Office
• Controlled/manufacturing area
Physical Requirements:
• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk and hear
• Be able to multitask
• Operate computer/office machines
Travel Estimate
20% of time in the initial phase
Education and Job Qualification
Required Qualifications:
- Bachelor’s in Pharmacy, Chemical Engineering, Industrial Engineering
- SAP PP/PI implementation expertise
- Strong GMP and regulatory understanding
- 5+ years in Pharma / Medical Device manufacturing or relevant experience
Preferred Qualifications
- Regulatory exposure
Experience
• Experience with MES/EBR/LIMS as part of manufacturing operations
• Project Management
• Lean/Six Sigma experience preferred
The presently-anticipated base compensation pay range for this position is $86,500 to $96,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.