Job Details

Job Description:

Production & Manufacturing Lead – Non-sterile Liquid Pharmaceutical Formulations

Position Summary

The Production & Manufacturing Lead is responsible for planning, coordinating, and supervising all aspects of daily production operations for pharmaceutical formulations. This role ensures compliance with GMP, regulatory requirements (e.g., FDA, EMA), and the company's internal quality and safety standards, while driving productivity, efficiency, and continuous improvement in a contract manufacturing (CDMO) setting.

Key Responsibilities

Production Oversight

• Plan, coordinate, and oversee daily production activities to meet manufacturing schedules, delivery timelines, and customer expectations.
• Ensure processes consistently meet production targets, quality requirements, and regulatory compliance.
• Allocate personnel, materials, and equipment effectively to maximize output and minimize downtime.

Compliance & Quality Assurance

• Ensure all production activities comply with cGMP, FDA, EMA, and internal quality standards.
• Collaborate with Quality Assurance (QA) and Quality Control (QC) teams to investigate and resolve deviations, non-conformities, and batch discrepancies.
• Support regulatory audits, client inspections, and internal quality reviews.

Team Leadership

• Supervise, coach, and develop production staff including operators, technicians, and line supervisors.
• Conduct performance evaluations, training sessions, and succession planning initiatives.
• Foster a high-performance culture focused on accountability, safety, and collaboration.

Process Improvement & Technology

• Lead initiatives to optimize production processes, reduce cycle times, and eliminate inefficiencies.
• Apply Lean Manufacturing, Six Sigma, and other continuous improvement methodologies.
• Evaluate and recommend new equipment, technologies, and process enhancements.

Budget & Resource Management

• Develop and manage departmental production budgets, including labor, materials, and overhead.
• Monitor expenses and implement cost control strategies.
• Track and report production KPIs, metrics, and operational performance to senior leadership.

Cross-Functional Collaboration

• Partner with R&D, Engineering, Regulatory Affairs, and Supply Chain teams for tech transfers, new product introductions, and process validation activities.
• Participate in product scale-up, troubleshooting, and client onboarding discussions.
• Ensure seamless integration between production and upstream/downstream operations.

Documentation & Reporting

• Ensure accurate and timely completion of all batch records, cleaning logs, deviation reports, and production documentation.
• Maintain data integrity and documentation readiness for regulatory audits.
• Provide regular updates, dashboards, and reports to executive leadership.

Safety & Environmental Compliance

• Promote and maintain a safe, compliant, and hazard-free workplace.
• Enforce adherence to environmental, health, and safety regulations (OSHA, local/federal rules).
• Lead safety training, incident response, and corrective action programs.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemical Engineering, or related field (preferred)
• 5–10 years of experience in pharmaceutical manufacturing; minimum 2+ years in a leadership or supervisory role
• Strong background in liquid & semi solid formulations
• Deep knowledge of GMP, FDA regulations, and batch manufacturing
• Hands-on experience in CDMO/CMO environment strongly preferred
• Proficient in documentation, deviation handling, and troubleshooting processes
• Experience with Lean, Six Sigma, or similar methodologies (certification is a plus)