Sr. Director/Executive Director, Head of CMC

Frontier Medicines is seeking a highly motivated individual for the pivotal role of Head of CMC, based in either Frontier’s Boston or South San Francisco office. As the Sr. Director or Executive Director Head of CMC, you will play a critical role in shaping the future of our small molecule pipeline by leading the development and manufacturing of drug substances. You will oversee both internal and external resources, working closely with CDMOs to ensure the successful advancement of our cutting-edge compounds. This is an exciting opportunity to lead a dynamic team and make a significant impact on the field of drug development.

Requirements

What will you be doing?

• Strategic Leadership: As the Head of CMC, you will have overall responsibility for small molecule drug substance and drug product development and manufacturing from preclinical to commercial manufacturing.
• Process Chemistry Pharmaceutical Development Oversight: Manage drug substance process chemistry, pre-formulation and formulation development, scale-up, and manufacturing for GLP studies and GMP manufacturing at CDMOs of drug substance and finished drug product to supply clinical trial material (CTM).
• Process Optimization: Develop manufacturing processes that are scalable, safe, cost-effective, and environmentally friendly.
• Vendor Management: Oversee CRO/CDMOs, including selection, technology transfer, from starting materials (suitable for Phase 1/2 and late stage regulatory starting materials) for cGMP API manufacturing, pre-formulation and formulation characterization, bulk and labelled/packaged finished drug product, storage, maintenance and projection of CTM inventory.Expert Collaboration: Leverage external expert consultants in the field of drug substance, formulation, drug product, and supply chain logistics to assist in achieving project goals.
• Technical Excellence: Work with CROs to implement state-of-the-art practices to address challenges related to salt, polymorph, particle size attributes, synthesis, reaction kinetics, process safety, impurity profile management, drug product performance and phase-appropriate analytical development and quality control of CTM manufactring.
• Cross-functional Collaboration: Collaborate closely with Medicinal Chemistry to facilitate candidate nomination and support synthesis efforts.
• Problem Solving: Apply discipline excellence to solve synthesis, process design, production equipment, and scale-up challenges for drug substance; pre-formulation and formulation characterization, process development and scale-up for drug product; and identification and characterization of critical quality attributes to support appropriate analytical method development and enable controls.
• Project Management: In collaboration with the Development Project Lead, define timelines, production scale, and budget to support all development candidates.
• Regulatory Compliance: Work collaboratively with Quality Assurance and Regulatory teams to review analytical documents, stability results, manufacturing batch records, and regulatory documents related to drug substance, and approve them as required.
• Documentation: authore supportive technical development reports, Module 3 and assist CMC related regulatory sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions.CMC Support: Interact with cross-functional teams to provide CMC technical information, guidance, and support; and represent the company as the CMC expert before U.S. and European regulatory authorities.
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents, and technical reports that define a CMC program.

What are we looking for?

• Ph.D. in organic chemistry/pharmaceutical science or similar with 12 – 15 years or master’s and 15+ years experience in small molecule drug development and/or manufacturing in Biotech or pharma setting; experience with late phase and commercialization of CMC programs is preferred.
• Extensive experience with process chemistry and formulation development, scale-up, tech transfer, drug substance characterization and working with CDMOs
• Experience in cGMP manufacturing, leveraging, and managing CRO/CDMOs for the manufacture of regulatory starting materials and drug substances to drug product.
• Experience overseeing related areas for regulatory submissions and knowledge of current regulations.
• Experience with quality by design (QbD), process validations and statistical design of experiments (DOE) is preferred
• Experience with early through