Sterile MS&T Lead for Manufacturing Science

Amneal Pharmaceuticals LLC; Town of Brookhaven (NY); On-site; USD 145,000 - 160,000; Full time

Job summary

Amneal is seeking a technical leader to provide hands-on support for sterile manufacturing operations, including BFS and aseptic filling. The role acts as a bridge between Manufacturing, QA, QC Microbiology, Engineering, Validation, Regulatory, Supply Chain, and Product Development.

The candidate will drive validation lifecycle activities, investigations, and CAPAs, while leading or supporting scale-up, site transfers, and new product introductions.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Pharmacy, Chemical Engineering, or related field (Required).
• 5+ years in pharmaceutical manufacturing or MS&T, with sterile operations experience.
• 3+ years in sterile manufacturing and BFS, prefilled syringes, sterile filling, or aseptic filling.
• 5+ years in PPQ, CPV, process characterization, tech transfer, or CPP/CPV activities.

Responsibilities

• Provide technical leadership for sterile operations (BFS, prefilled syringes, bag filling, aseptic processing).
• Lead or support validation lifecycle activities and tech transfer initiatives.
• Investigate deviations, CAPAs, and batch disposition with cross-functional teams.
• Develop and improve control strategies and contamination control programs.
• Collaborate with Engineering, QA, Regulatory, and Supply Chain on qualifications and changes.
• Prepare/review technical documents and support audits and inspections.

Skills

Sterile manufacturing

Process engineering

Validation

Tech transfer

Regulatory inspections

Technical coaching

Education

Bachelor's degree in Pharmaceutical Sciences or related

Tools

Minitab

JMP

Job description

Amneal is seeking a technical leader to provide hands-on support for sterile manufacturing operations, including BFS and aseptic filling. The role acts as a bridge between Manufacturing, QA, QC Microbiology, Engineering, Validation, Regulatory, Supply Chain, and Product Development.

The candidate will drive validation lifecycle activities, investigations, and CAPAs, while leading or supporting scale-up, site transfers, and new product introductions.