Production Manager​/Director

Manager / Director of Production – Injectable Products

Location:

East Windsor, NJ (On-site)

Reports To:

COO

Please contact:  or

The Manager/Director of Production is responsible for leading and overseeing all manufacturing operations related to sterile and complex injectable pharmaceutical products. This role ensures safe, efficient, and compliant production in accordance with FDA cGMP requirements, while meeting production schedules, quality standards, and cost objectives. The position provides both strategic and hands‑on leadership for compounding, aseptic filling, lyophilization, and packaging operations.

• Lead day‑to‑day production activities for sterile injectable products, including compounding, aseptic filling, lyophilization, inspection, and packaging.
• Ensure manufacturing operations are executed in compliance with cGMP regulations (21 CFR Parts 210/211) and internal procedures.
• Plan, schedule, and execute production campaigns to meet commercial, clinical, and development requirements.

• Ensure proper execution of aseptic techniques, gowning practices, environmental monitoring, and contamination control strategies.
• Maintain state of control for clean rooms, isolators, and critical manufacturing equipment.
• Collaborate with Quality Assurance to investigate and resolve deviations related to sterile processing.

• Develop production plans, staffing models, and shift schedules to support manufacturing demands.
• Ensure availability of raw materials, components, and consumables in coordination with Supply Chain and Warehouse teams.
• Manage production budgets, labor utilization, and operational costs.

• Ensure accurate, timely execution and completion of batch records, logbooks, and manufacturing documentation.
  
  Review production documentation for completeness and compliance prior to QA review.
  
  Support right‑first‑time batch execution and continuous improvement initiatives. Equipment & Facility Management
  • Oversee operation, maintenance, and troubleshooting of manufacturing equipment including mixers, homogenizers, filtration systems, filling lines, lyophilizers, and CIP/SIP systems.
  • Support equipment qualification, process validation, and scale‑up activities in collaboration with Engineering and QA.
  • Participate in facility upgrades, process improvements, and capacity expansion projects.
  Regulatory & Inspection Support
  • Act as a key manufacturing representative during FDA inspections, customer audits, and regulatory agency visits.
  • Ensure production readiness for inspections and support timely responses to observations related to manufacturing operations.
  • Lead, train, and develop production staff including supervisors, operators, and technicians.
  • Promote a strong culture of compliance, safety, accountability, and continuous improvement.
  • Establish performance expectations, conduct performance reviews, and support employee development.
  Cross‑Functional Collaboration
  • Partner closely with Quality Assurance, Quality Control, Engineering, R&D, Regulatory Affairs, and Supply Chain to support product lifecycle activities.
  • Support technology transfer, process development scale‑up, and introduction of new injectable products.
  Qualifications Education
  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related technical discipline (Master’s degree preferred).
  Experience
  • Manager level: Minimum 8–10 years of manufacturing experience in pharmaceutical production, with at least 5 years focused on sterile injectable products.
  • Director level: Minimum 12–15 years of progressive manufacturing leadership experience in sterile injectable operations.
  • Direct experience with aseptic processing, sterile filling, and GMP manufacturing is required.
  • Experience supporting FDA inspections and regulatory audits is strongly preferred.
  • Strong knowledge of sterile manufacturing operations and cGMP requirements.
  • Proven leadership and people‑management skills in a regulated environment.
  • Excellent problem‑solving and decision‑making abilities.
  • Strong organizational, communication, and planning skills.
  • Ability to manage multiple priorities in a fast‑paced manufacturing environment.
  Working Conditions
  • On‑site role in a GMP manufacturing facility and cleanroom environment.
  • May require off‑shift or weekend support during manufacturing campaigns or regulatory inspections.

  For Doz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). For Doz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics