Head of Sterile Product Development and CTM Manufacturing-CMC
Exton, PA (Research)
Head of Sterile PD/CTM is responsible for leading a team of scientists and project leaders supporting R&D and GMP process development for clinical trial material (CTM) manufacturing of pharmaceutical parenteral, ophthalmic and other dosage forms.
- Manage a team of scientists and project leaders for multiple projects at various stages of product development, including pre-formulation, formulation development, process development, optimization, scale-up studies/technology transfer
- Incorporate Quality-by-Design (QbD) initiatives in the product development program
- Provide technical training, guidance, and hands-on training to junior scientists assisting with study executions for aseptic development and manufacturing of injectables, ophthalmics, etc., media fills, and environmental monitoring
- Write, review and approve product development report (PDR) and GMP documentation for CTM manufacturing, including manufacturing batch records, finished product specifications, SOP’s, change controls, etc.
- Manage project related scientific/technical activities, project management and communication with project sponsors to meet their expectation.
- Manage project priorities and resources to ensure project timelines
- Evaluate the need for new equipment, technology and procedures to be implemented in-house to expand current capabilities
- Collaborate with other teams (BD, client services, Analytical Scientists, Quality Assurance and Manufacturing Technicians) to ensure project completion
- Ph.D. in Pharmaceutics, Chemistry, Polymer Chemistry or Chemical Engineering, with 8-10 years of experience, or Master’s with equivalent experience
- Hands on experience in sterile product development including emulsion, suspension, and lipid-based delivery systems. Protein/biologics experience is a plus.
- Solid knowledge in sterile product development and manufacturing per cGMP compliant procedures, as well as for IND and ANDA
- Excellent written and verbal communication and presentation skills
- Excellent people skills
- CRO experience is a plus.