Position Summary
Leading and directing the formulation development function for strategies plans critical to discovery and development programs. Collaborating with CDMO/CROs and internal different line functions to provide technical guidance of pre-formulation; clinical formulation design, characterization, process development and related CMC activities.
Essential Duties and responsibilities
Develop drug product formulation and manufacturing processes for new chemical entities in pre-clinical and clinical programs with focus on formulation process design, technology selection, process development, process data analysis, fundamental process understanding, and drug product characterization.
Responsible for the design, planning, execution and delivery of formulation and process development studies, toxicology study/clinical supplies, process performance qualification and technology transfer for oral and sterile liquid and/or lyophilized parenteral drug products for small and large molecules.
Collaborate with cross-functional teams, including Process Development, Analytical Development, and Regulatory, to ensure effective integration and alignment of efforts
Ensure that all formulation development activities comply with regulatory requirements and current Good Manufacturing Practice (cGMP);
Serve as drug product subject matter expert to program teams for programs from early development through registration.
Design and develop strategies for the Pharmaceutical R&D function, technical capabilities, and work flows
Collaboratively manage and provide technical guidance to CROs and CDMOs in research and development of drug products, including R&D and manufacturing schedules at multiple CMOs
In collaboration with regulatory, author relevant Chemistry, Manufacturing and Controls (CMC) sections for drug products and address Regulatory reviewer comments with data supporting responses to enable accurate and timely registrational submission.
Collaborate with Quality in developing stability studies for drug product intermediate and finished drug product to support shelf-life.
Collaborate with Analytical in developing Drug Product Specifications justifications and testing requirements.
Provide guidance on quality control strategies and operations from early development through registration for all development candidates.
Provide input on program development strategies, budgets, and timelines to ensure that both technical and business requirements are achieved.
Core Competencies, Knowledge and Skill Requirements
Ph.D. in pharmacy, chemistry, materials science, or related physical science. A combination of relevant education and applicable job experience may be considered.
Minimum 10 years of Formulation and Pharmaceutical Development experience in the biotech/pharmaceutical industry
Proven-track record in formulation development and delivery across a range of molecules, and through all stages of development, including performance qualification and NDA/MAA
Strong leadership and management abilities
A critical and strategic thinker with exceptional decision making ability
Excellent communication, problem-solving and organizational skills; thrives in a cross-functional team environment
Extensive knowledge and experience in GxP practices, ICH guidelines, and other regulatory practices
Up to date knowledge of modern technology and emerging research areas of pharmaceutical science
Familiar with analytical methods and instrumentation used to characterize APIs, dosage forms, and drug products
Understanding of chemical and physical properties of APIs and excipients associated with formulation, process and drug delivery
