Executive Search: Group Leader – Senior Manager, Sterile Product Development & Clinical Trial Manufacturing, Pharmaceutical

Executive Search: Group Leader – Senior Manager, Sterile Product Development & CTM Pharmaceutical Manufacturing

Pharma-Cruiting Life Sciences Executive Search is seeking a Group Leader, Senior Manager of Sterile Product Development, CMC and Clinical Trial Material Manufacturing for our pharmaceutical manufacturing client.

The Manager or Senior Manager, Sterile Product Development & CTM Manufacturing will be 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.

Responsibilities

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.

Requirements

  • 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.

Email ruth@pharmacruiting.com to apply or submit resume below.