Manager, Clinical Trial Material (CTM) Manufacturing Support-CMC
Exton, PA (Research)
Manager, Clinical Trial Material (CTM) Manufacturing Support
Exton, PA (CMC)
The Manager, Manufacturing Support position is responsible for coordinating and supporting GMP operations including manufacturing, equipment, raw materials, warehouse, etc. in support of Clinical Trial Material (CTM) manufacturing.
• Lead and train a team of people to support GMP operations including manufacturing, equipment, raw materials, etc.
• Facilitate production of GMP clinical batches in conjunction with project leaders and formulation scientists.
• Document and review all manufacturing and maintenance activities and events in logbooks following SOPs and documentation practices. Document and review all cleaning activities and events in logbooks following SOPs and documentation practices.
• Provide scheduled cleanings per SOPs throughout the facility to include GMP manufacturing rooms, R&D laboratories, warehouse and other areas as needed in order to maintain and conform to FDA and cGMP guidelines and regulations for cleaning practices. Clean GMP and R&D equipment as needed to the standards necessary to meet cleaning validation requirements.
• Facility maintenance and equipment maintenance coordination according to the calibration schedule and GMP manufacturing schedule.
• Assist with drafting SOPs, qualification protocols, change controls, relevant CAPAs, and other GMP documentation.
• Assign team personnel and be involved in tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of solid, semi-solid, and sterile formulations. Participate in media runs for aseptic fill projects.
• Assist with manufacturing area maintenance such as area monitoring and qualification per applicable SOPs and maintain records, purchase of equipment and room cleaning supplies.
• Work with project leaders to assess project priorities and work out a plan to assign resources, such as personnel, equipment, etc. to meet project timelines.
• Collaborate with team members (Formulators, Analytical Scientists, Quality Assurance and Manufacturing Technicians) to assist in working out investigation plans related to manufacturing investigations as required.
• Follow company policies and conduct work according to appropriate Frontage SOPs and comply with cGMP guidelines.
• Bachelor’s degree or equivalent with 5-10 years pharmaceutical industry experience.
• Hands on experience in pharmaceutical manufacturing per cGMP compliant procedures.
• Familiarity and working knowledge of manufacturing processes, equipment set-up, operation, cleaning, etc. for various pharmaceutical dosage forms.
• Strong written and verbal communication skills.