Sterile Injectable Manufacturing Leader - Ops & Compliance

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 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