Manufacturing Process Owner - Drug Product Formulation (SAP S/4 HANA Enablement)

Manufacturing Lead

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 FITGAP, 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:

Bachelors in pharmacy, Chemical Engineering, Industrial Engineering

Working knowledge of SAP PP/PI in a manufacturing environment

Strong GMP and regulatory understanding

Preferred Qualifications:

Regulatory exposure

Experience:

7-12 years in pharma manufacturing

Experience with MES/EBR/LIMS as part of manufacturing operations

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.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.