Head of Production (Sterile Injectables)

About the role

The Head of Production serves as the senior leader responsible for all sterile manufacturing operations at Penn Life Sciences. This role provides strategic and operational leadership across aseptic production functions including component preparation, formulation and compounding, aseptic filling, visual inspection, and packaging. The position ensures manufacturing operations are executed safely, efficiently, and in full compliance with cGMP regulations and regulatory expectations governing sterile pharmaceutical manufacturing.

Responsibilities

• Provide leadership and oversight for all sterile manufacturing operations including component preparation, formulation and compounding, aseptic filling, visual inspection, and packaging activities.
• Develop and execute production strategies to support site manufacturing objectives, product supply commitments, and operational performance targets.
• Ensure manufacturing activities comply with all applicable cGMP regulations, internal quality systems, and regulatory expectations for sterile drug product manufacturing.
• Maintain manufacturing operations in a continuous state of audit readiness and support regulatory inspections, internal audits, and customer audits.
• Lead manufacturing investigations, deviations, CAPAs, and change control activities impacting production operations.
• Establish and monitor key performance indicators (KPIs) related to safety, quality, delivery, and productivity to drive operational accountability and continuous improvement.
• Drive operational excellence initiatives aimed at improving manufacturing efficiency, reducing waste, and enhancing process reliability.

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline required; Master’s degree preferred.
• Minimum 8–15 years of progressive experience in pharmaceutical manufacturing operations within a regulated cGMP environment.
• Minimum 5–12 years of leadership experience within sterile or aseptic pharmaceutical manufacturing environments.
• Demonstrated experience overseeing manufacturing operations such as formulation or compounding, aseptic filling, visual inspection, and/or pharmaceutical packaging.
• Strong working knowledge of FDA cGMP regulations and regulatory expectations governing sterile drug product manufacturing.
• Experience supporting regulatory inspections and maintaining audit-ready manufacturing operations.
• Demonstrated experience leading manufacturing investigations, deviations, CAPAs, and change control activities.
• Proven leadership capability with experience developing and managing production teams within regulated pharmaceutical manufacturing environments.

Qualifications

• Minimum 8–15 years of progressive experience in pharmaceutical manufacturing operations within a regulated cGMP environment.
• Minimum 5–12 years of leadership experience within sterile or aseptic pharmaceutical manufacturing environments.
• Demonstrated experience overseeing manufacturing operations such as formulation or compounding, aseptic filling, visual inspection, and/or pharmaceutical packaging.
• Strong working knowledge of FDA cGMP regulations and regulatory expectations governing sterile drug product manufacturing.
• Experience supporting regulatory inspections and maintaining audit-ready manufacturing operations.
• Demonstrated experience leading manufacturing investigations, deviations, CAPAs, and change control activities.
• Proven leadership capability with experience developing and managing production teams within regulated pharmaceutical manufacturing environments.

Skills

• Strategic and operational leadership skills.
• Experience with cGMP regulations and regulatory expectations.
• Leadership experience in sterile or aseptic pharmaceutical manufacturing environments.
• Experience with manufacturing operations such as formulation or compounding, aseptic filling, visual inspection, and/or pharmaceutical packaging.
• Experience with regulatory inspections and maintaining audit-ready manufacturing operations.
• Experience with manufacturing investigations, deviations, CAPAs, and change control activities.
• Experience with developing and managing production teams within regulated pharmaceutical manufacturing environments.

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays

Pay

Compensation is commensurate with experience.

Schedule

Full-time position.