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.

Location(s):

• Greater San Francisco Bay Area, CA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.