Senior Sterile Fill/Finish Operations Leader

Halo Pharma; Northern (KY); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Halo Pharma is seeking a Sterile Injectable Manufacturing Manager to oversee aseptic fill/finish operations at the Whippany, NJ site. This senior role requires leading cross-functional teams to ensure safe, compliant, and efficient production of sterile dosage forms across multiple programs.

The role focuses on capacity planning, regulatory compliance, continuous improvement, and collaboration with QA, Supply Chain, and project management.

Qualifications

• 10–15 years of pharmaceutical manufacturing experience, incl. sterile fill/finish.
• 7–10 years of leadership in sterile injectable manufacturing operations.
• Hands-on experience with isolator-based filling systems.
• Experience with greenfield or new sterile line startups and CQV.
• Experience leading deviations and CAPA in sterile manufacturing.

Responsibilities

• Lead all sterile injectable manufacturing operations to meet safety, quality, and production targets.
• Develop and manage capacity models, schedules, and asset utilization.
• Coordinate with Supply Chain and Project Management for demand forecasts and tech transfers.
• Drive KPI visibility and performance reviews aligned with site strategy.
• Lead capital projects and cross-functional teams for process improvements.

Skills

Aseptic leadership

Lean Six Sigma

Project management

Cross-functional

Regulatory compliance

Troubleshooting

Education

Bachelor's in Engineering

Lean Six Sigma Green Belt

PMP

Tools

IQ/OQ/PQ

CQV

Job description

Halo Pharma is seeking a Sterile Injectable Manufacturing Manager to oversee aseptic fill/finish operations at the Whippany, NJ site. This senior role requires leading cross-functional teams to ensure safe, compliant, and efficient production of sterile dosage forms across multiple programs.

The role focuses on capacity planning, regulatory compliance, continuous improvement, and collaboration with QA, Supply Chain, and project management.