The Scientist – Associate Director, Product Development will be responsible for leading formulation and product development activities with emphasis on small molecule oral drug product formulations. Responsible for designing, executing, and analyzing results, formulation, and process development study. The incumbent will apply enabling technologies to develop bioavailable immediate release (IR) and modified release (MR) formulations and robust manufacturing processes. Experienced in dissolution enhancing formulations for Biopharmaceutics Classification System (BCS) Class II compounds is desirable. This individual will be hands-on in the laboratory, while acting as a subject matter expert leading product development activities from preclinical stage through product registration and commercialization. Title will be commensurate with experience.
- Design and develop drug product formulations of immediate release (IR) and modified release (MR) formulations and manufacturing processes of small molecule drug candidates to support clinical trials and commercialization
- Lead the design and execution of pre-formulation activities (hands-on), such as solubility, stability, and excipient compatibility studies, and determine physicochemical properties of NCEs
- Write and execute (hands-on) study protocols for developing and trouble-shooting formulation issues
- Lead material characterization (hands-on), e.g., physical and polymorphic forms, particle size distribution, morphology, hygroscopicity, DSC, TGA, and powder flow to understand their impacts on drug product performance
- Actively supervise and manage CRO/CMO activities to achieve CMC milestones and project timelines. Ascertain on time delivery of clinical, stability, registration, and validation batches
- Develop and propose project plan and seek alignment with manager and functional heads
- Develop contingency plan to ascertain timely CTM manufacture and packaging for un-interrupted clinical supply
- Design stability studies for various stages of formulation development
- Responsible for scale-up and technology transfer of manufacturing processes to global contract manufacturing sites
- Proactively identify potential issues and develop creative solutions or contingency in order to achieve project goals
- Lead efforts to write technical reports to document results of experimentation performed by contract laboratories
- Write regulatory documents, e.g., CMC sections of CTD, development study protocols, and other cGMP related documents as needed
- Adhere to budgets, resources, and timelines to achieve successful project completion
- Represent the formulations group in various inter-disciplinary meetings and communicate findings to department managers
- Travel up to 15%
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering or other relevant discipline
- Minimum 3 years’ experience with PhD degree (5 years with BS or MS degree) working in a pharma/biotech R&D and cGMP regulated manufacturing environment with proven expertise in formulation development of small molecules and solid oral dosage forms is required.
- Experience working with and overseeing CMOs/CROs is required
- Experience authoring CMC section for regulatory (IND/NDA) submissions is preferred
- Good knowledge of quality and regulatory requirements including FDA and ICH guidelines
- Experience applying DoE and QbD principles to formulation and process development
- Ability to work independently and as a self-starter in a fast-paced environment
- Ability to work at a high level of collaboration with cross-functional colleagues.
- Exceptional written and oral communication, collaboration and creative problem-solving skills ensuring alignment with other functions.