Production ManagerDirector
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Job Location:
East Windsor, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Manager / Director of Production Injectable Products
Location: East Windsor NJ (On-site)
Reports To: COO
Position Summary
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.
Key Responsibilities
Manufacturing 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.
Aseptic Processing & Sterile Manufacturing
- Ensure proper execution of aseptic techniques gowning practices environmental monitoring and contamination control strategies.
- Maintain state of control for cleanrooms isolators and critical manufacturing equipment.
- Collaborate with Quality Assurance to investigate and resolve deviations related to sterile processing.
Production Planning & Resource Management
- 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.
Batch Execution & Documentation
- 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.
Team Leadership & Development
- 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
- Bachelors degree in Engineering Pharmaceutical Sciences Chemistry or a related technical discipline (Masters 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.
Skills & Competencies
- 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.
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- Lean
- Management Experience
- 5S
- Operations Management
- Production Planning
- Production Management
- Kaizen
- Supervising Experience
- Manufacturing
