Director, CMC Formulation Development

We are currently seeking a highly motivated, creative CMC formulation professional at associate director or director level to join our CMC team in San Diego.

Role responsibilities

• Understand the development candidate’s physicochemical properties and target product profile to evaluate formulation options and design phase appropriate formulations at different development stages.
• Select external CRO/CDMO partners based on project needs and the external parties’ technical capabilities, quality system, and track records. 
• Prepare RFPs and evaluate proposals based on the targeted product quality, project timeline, and budget.
• Plan and oversee drug product process optimization, GMP manufacturing, packaging, labeling, stability testing activities.
• Track process development/validation history and manage CMC drug product related documents in support of life cycle of quality improvement and regulatory filing/updates.
• Work closely with a cross-functional team within and outside of the CMC department to align with key stakeholders (CMC, Clinical, Quality Assurance and Regulatory).
• Author and review CMC drug product related sections for regulatory filing and annual updates.
• Stay current on industry trends and regulatory requirements to ensure delivery of quality products under cGMP environment.
• Prepare and communicate research results in both oral and written format.
• Supervise junior CMC Drug product team members.
• Contribute to a fast-paced, dynamic, data-driven scientific culture that embraces innovation and excellence. 

• Ph.D. or M.S. in chemistry, chemical engineering, pharmaceutical science, or related discipline with at least 10 years of industry experience (title for this position will be commensurate with the candidate’s experience and qualifications) 
• Highly familiar with current formulation principles and industry practices.
• Extensive process development/ optimization, scale-up and process validation expertise, with emphasis on solid oral dosage forms.
• Experience with injectable formulations and modern enabling technologies is a plus.
• Track record of accomplishment in managing CMC drug product projects at early and late development stages.
• Ability to enable external CRO/CDMO to achieve project goals on time and under budget.
• Strong written and communication skills, good problem-solving abilities, and an ability to work effectively with a diverse team of co-workers in a dynamic environment.