Director, CMC Preformulation Sciences

Summary:We are seeking a Director or Senior Director, CMC Preformulation Sciences to join our growing Chemistry, Manufacturing, and Controls (CMC) team. This leadership role will drive preclinical formulation strategies, ensuring the seamless translation of discovery compounds into clinical candidates. The successful candidate will be responsible for evaluating the pharmaceutical properties of drug candidates, guiding formulation strategies for preclinical and early clinical development, and collaborating closely with cross-functional teams (DMPK, Toxicology, Pharmacology, Medicinal Chemistry) to address challenges related to solubility, stability, bioavailability, and drug delivery.This individual will provide strategic leadership and technical expertise in preclinical formulation development while actively contributing to candidate selection, optimization, and progression. A strong ability to lead teams, influence decision-making, and navigate a fast-paced biotech environment is essential.Essential Duties and Responsibilities:Provide strategic leadership in preclinical formulation development, ensuring robust assessment of drug candidates' physicochemical properties and developability.Lead the design, characterization, and optimization of formulations to support in vivo pharmacology, DMPK, and toxicology studies.Integrate preformulation and biopharmaceutics strategies within CMC emphasizing strategic, staged determination of solid state and preclinical formulations to enable early determination of a qTPP driving candidate selection.Serve as the biopharmaceutics lead within CMC, working closely with discovery, DMPK, pharmacology, toxicology, and product development teams to ensure seamless candidate progression.Manage a laboratory-based team to oversee the selection and characterization of solid-state forms (e.g., polymorph/salt selection), including analytical techniques such as PXRD, DSC, TGA, DVS, microscopy, UPLC/HPLC, dynamic light scattering, particle size analysis, and solubility/stability assessments.Develop and implement formulation strategies for poorly soluble small molecules, leveraging techniques such as particle size reduction, lipid-based formulations, amorphous solid dispersions, and self-emulsifying drug delivery systems.Provide guidance on clinical formulation design, including dose selection, administration routes, and early-phase drug product development.Lead and mentor a team of scientists, fostering technical excellence and career development.Establish and manage relationships with external CROs/CDMOs for preclinical and early-phase formulation development.Stay abreast of emerging trends in formulation sciences, drug delivery technologies, and regulatory expectations.Qualifications and Experience:Ph.D. or advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.12+ years of industry experience with demonstrated strategic leadership in preclinical formulation and early drug development.Deep understanding of formulation impacts on ADME, preclinical safety, and drug development.Proven track record of successfully advancing drug candidates through preclinical and early clinical development.Experience leading cross-functional teams and influencing strategic decisions, as well as managing a group of internal laboratory scientists and external partnersStrong background in physicochemical characterization and solid-state properties of drug candidates.Expertise in formulation development strategies for challenging molecules, including solubility and bioavailability enhancement approaches.Strong project management skills, with the ability to drive programs forward in a dynamic environment.Excellent written and verbal communication skills, with the ability to present complex data to diverse audiences.

Created: 2025-03-03