Senior CMC Director - WALKER COLE INTERNATIONAL LTD : Job Details

Walker Cole International is searching for a Senior CMC Director (Formulation) to join a growing specialty pharmaceutical business in the South of England.

As the Senior CMC Director (Formulation), you will be responsible for leading scientific innovation across the company’s portfolio of both established and new products. You will be responsible for overseeing Research and Development, Formulation, Process Development, Product Launch and Chemistry Manufacturing & Controls (CMC) activities for the business.

Main Responsibilities:

• Lead CMC/Research & Development strategies and product development/formulation processes for a variety of products (complex generics, biosimilars, novel therapies, etc.)
• Oversee scientific, compliance, and sustainability efforts to meet industry regulations.
• Collaborate cross-functionally with various departments to ensure R&D projects meet market and legal requirements.
• Team Leadership, Budget management and timeline optimization.

Academic and Work Experience required:

• PhD (or equivalent) in relevant scientific discipline.
• Significant leadership experience in R&D and product development/formulation science/analytical methods within the pharmaceutical industry.
• Proven success in bringing pharmaceutical products to market, (concept to launch).
• Knowledge of and experience with regulatory submissions (Regional/Global) and CMC.

Product Development | Research and Development| Strategy | Scientific Innovation | Pharmaceutical | Formulation | Regulatory Compliance | Speciality Drugs | Generics | Biosimilars | Chemistry | Biology | Formulation | Chemistry Manufacturing & Controls | CMC | R&D | Process Development | Technology Transfer | Oral Solid Dose | Liquid | Scale Up | API | Active Pharmaceutical Ingredient | Drug Product | Drug Substance | ICH Q8 | CMO | Contract Manufacturing Organisation