Position Summary:
We are seeking a highly motivated and detail-oriented Drug Product Manufacturing Specialist to join our GMP drug product production team. This role will support the Head of the GMP Pilot Plant in the manufacturing of drug products for early-phase clinical studies. The successful candidate will oversee both GMP compliance and the operation of processing equipment, ensuring high-quality drug product manufacturing while maintaining adherence to regulatory standards.
Key Responsibilities:
Manufacturing Operations:
• Execute and oversee drug product manufacturing processes, including equipment setup, operation, cleaning, and maintenance.
• Support the production of solid and liquid drug products in compliance with GMP guidelines.
• Troubleshoot and optimize manufacturing processes and equipment to ensure efficiency and quality.
GMP Compliance and Documentation:
• Prepare and maintain GMP documentation, including batch records, SOPs, and equipment logs.
• Perform quality checks on manufacturing activities to ensure alignment with regulatory requirements.
• Participate in GMP audits and implement corrective actions to address findings.
• Ensure proper traceability and documentation for all raw materials, intermediates, and final products.
Collaboration and Team Support:
• Work closely with cross-functional teams, including formulation scientists, quality assurance, and analytical development.
• Train and supervise technicians on GMP processes, equipment operation, and documentation practices.
• Assist in the transfer of processes from development to GMP manufacturing, providing technical support and troubleshooting expertise.
Equipment Management:
• Operate and maintain processing equipment, such as granulators, fluid bed dryers, spray dryers, capsule fillers, and tablet presses.
• Perform periodic calibration and qualification of manufacturing equipment.
• Collaborate with engineering teams to ensure equipment readiness and address technical challenges.
Continuous Improvement:
• Identify opportunities to enhance manufacturing processes, reduce waste, and improve efficiency.
• Stay updated on industry trends and regulatory changes to ensure best practices in GMP manufacturing.
Qualifications:
• Education: Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, or a related field.
• Experience: 5+ years of experience in GMP drug product manufacturing, preferably in a pilot plant or early-phase clinical setting.
• Familiarity with manufacturing processes such as blending, granulation, compression, coating.
• Strong knowledge of GMP guidelines and regulatory requirements for drug product manufacturing.
• Proficiency in preparing and reviewing GMP documentation.
Key Skills:
• Strong organizational skills with attention to detail.
• Excellent problem-solving and troubleshooting abilities.
• Ability to train and mentor junior staff.
• Effective communication skills for cross-functional collaboration.
• Technical aptitude for operating and maintaining complex manufacturing equipment.
Work Environment:
• Hands-on work in a pilot plant setting, requiring adherence to safety and cleanliness protocols.
• Occasional lifting of equipment components or raw materials may be required.