Head of Production (Sterile Injectables)

Penn Life Sciences; Langhorne (Bucks County); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

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

Job summary

Penn Life Sciences in Langhorne, PA seeks an experienced Head of Production to lead all sterile manufacturing operations, including aseptic filling, component preparation, formulation, visual inspection, and packaging. The role ensures safe, compliant, and efficient production in a cGMP environment.

The ideal candidate has 8–15 years in regulated pharma manufacturing and 5–12 years of leadership in aseptic settings, with a track record of process improvement, investigations, CAPAs, and audit

Qualifications

• Bachelor’s or higher in a relevant scientific field or engineering.
• Minimum 8–15 years in pharmaceutical manufacturing operations.
• Minimum 5–12 years in leadership within sterile/aseptic environments.

Responsibilities

• Provide leadership for all sterile manufacturing operations including preparation, formulation, aseptic filling, inspection and packaging.
• Develop and execute production strategies to meet site objectives and product supply commitments.
• Ensure compliance with cGMPs and regulatory expectations for sterile drug products.

Skills

Leadership experience

Regulatory compliance

Aseptic processing

Process improvement

Audit readiness

KPI management

Cross-functional leadership

Education

Bachelor's degree in Engineering/Pharma Sciences/Chemistry

Master's degree preferred

Job description

Penn Life Sciences is seeking an experienced Head of Production to join our team in Langhorne, PA. 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. The ideal candidate will bring extensive experience leading sterile injectable manufacturing operations, a strong understanding of aseptic processing and contamination control, and a demonstrated ability to build and lead high-performing production organizations.

This position’s responsibilities will include, but not be limited to the following:

• 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.

We Are Looking For Applicants With

• 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.

What We Offer

• 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

Penn Life Sciences is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.