Director, Drug Product and Process Development

Job Description Summary
Director, Formulation Development is an experienced leader in the development of pharmaceutical products in a virtual environment with extensive technical, strategic and leadership expertise in guiding teams and driving results. Leveraging their deep technical proficiency and proven cross-functional collaboration, they will empower decision making while serving as a product development expert to all relevant internal and external functional representatives (CMOs, Manufacturing, Supply Chain, Quality Assurance, Regulatory, etc.)

to deliver products that are commercially viable and that meet the highest standards of quality and safety for patients. In addition, the role requires a successful track record of carrying out development, manufacturing, and commercialization activities including a demonstrated ability to work effectively with CDMOs. The position reports to Executive Director, CMC & Product Development.

• You will be responsible for leading the strategic and technical aspects of solid oral dosage products manufactured at contract development and manufacturing organizations (CDMOs). Responsibilities include formulation development, process development, scale-up, process validation/process performance qualification, technology transfer and providing day to day support for GMP manufacture of drug products at external CDMOs.

• You will partner with CDMOs and internal functional groups to establish and maintain robust business and technical relationships related to the development and manufacturing of drug products. The Director will be responsible for leading the design, development and technology transfer of manufacturing processes, as well as managing day to day support for GMP manufacturing.

• Oversee the entire CMC drug development process for drug products from preclinical to clinical stages, ensuring self and project teams are acting in compliance with GMP and US and global regulatory requirements (FDA, ICH, EMEA, and WHO) and industry standards.

• Lead and mentor a team of scientists, researchers, and engineers, fostering a culture of excellence, collaboration, and professional growth.

• Drive the formulation development, process optimization, scale-up, and technology transfer activities to ensure efficient and effective development of drug products.

• The Director should be knowledgeable in managing the budget for projects

• Drive continuous improvement initiatives, identify opportunities to optimize development processes, and implement best practices to enhance efficiency and quality.

• Collaborate with the quality assurance and regulatory teams to support technology transfer, scale-up, and commercialization of pharmaceutical products.

• The Director should be experienced in managing pharmaceutics, immediate and modified release formulation development for solid oral dosage forms or immediate and extended-release parenteral dosage forms, including injectables, infusions, and implants, long acting injectables, product life cycle management, and process analytics.

• You will be responsible for guiding team members, and for maintaining expertise in state-of-the-art production equipment, development of dosage forms, and maintaining regulatory compliance in all aspects of dosage form manufacturing.

• Author, review, and approve technical documents, including development plans, protocols, reports, and regulatory submissions.

• The position may involve travel from 10 - 40%.

• BS or MS in Pharmaceutical Sciences, Organic Chemistry, Chemical Engineering, or related field with a minimum 15 years of experience in the biopharmaceutical industry

• PhD in Pharmaceutics, Pharmaceutical Sciences, Organic Chemistry, Chemical…