Associate Director, Pharmaceutical Development

Junto HLS is working directly with Pharm Dev/ Formulations leadership at a growing pharmaceutical client, local in the Bay Area, to recruit an Associate Director, Pharmaceutical Development.

Position Overview:

  • Design and develop robust, scalable formulations, manufacture prototype dosage forms, and conduct drug product process development and process optimization activities in-house.
  • Evaluate and select contract service providers (CSPs), conduct tech transfer, plan and oversee scale-up activities, manufacture engineering batches and clinical trial materials, and manage the manufacturing of drug product for process validation, registration, and commercialization.
  • Prepare and review manufacturing and executed batch records, draft and review formulation and product development reports, and reports from CSPs.
  • Support regulatory submissions by drafting and reviewing drug product sections of INDs, NDAs and IMPDs, and ensure compliance with current regulatory requirements.
  • Lead CMC team as needed and represent the department at CMC and project meetings and work closely with cross-functional teams (Technical Operations, Quality Assurance, Clinical Pharmacology, Development and Operations, and Regulatory Affairs) to meet project timelines and goals.
  • Manage and operate various instruments used in formulation development and carryout preformulation activities as needed for the projects.
  • Travel to the sites of CSPs to oversee the manufacturing activities.
  • Keep abreast of latest developments in drug product manufacturing technologies, cGMP requirements, regulatory guidance, and drug delivery approaches to drive new product development and lifecycle management.


    • Greater San Francisco Bay Area, CA

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