Director, Product Development

The Director, Product Development is responsible for formulation development, scale up, technology transfer, manufacturing of GMP, clinical, registration stability, and validation batches of clinical-stage solid oral products. This is a highly visible leadership position with responsibility of managing the studies and manufacturing batches at the Contract Manufacturing (CMO) partners. Responsible for designing the process development studies, manufacture of clinical and registration batches.
MAJOR DUTIES AND RESPONSIBILITIES:

• Overall responsibility for global drug Product Development of late-stage solid oral products
• Work with CMO to design studies to develop a robust, commercially viable formulation and process for these products
• Transfer the technology from clinical-stage CMO to a late-stage CMO, as necessary
• Represent CMC function in the core Project Team
• Responsible for continuous improvement throughout drug product manufacturing, including process validation up to commercialization
• Support cross-functional project teams and work closely with Analytical Sciences and Stability, Quality Assurance, Clinical Supply Chain, and Regulatory as well as external Contract Organizations to ensure timely and effective execution of related tasks
• Provide technical project management support for all clinical drug product manufacturing activities including batch record reviews
• Author or review protocols, technical reports, articles and portions of regulatory submissions
• Proactively identify potential issues and develop creative solutions to technical problems in order to keep projects on schedule
• Identify and manage process improvement activities for clinical manufacturing operations
• Act as the technical subject matter expert (SME) internally for troubleshooting formulation and process issues
• Maintain process trend data and understand the impact of process changes on the formulation performance
• Coordinate and develop business processes related to the transfer of drug product processes from the development site to the manufacturing site
• Interact with outside patent counsel in helping draft patent applications for any new formulations
• Other duties as assigned.
• Travel: Up to 20%

EDUCATION REQUIREMENTS:

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

EXPERIENCE REQUIREMENTS:

• A minimum of 10 years' experience, with a minimum of 5 years' experience in leading the formulation development of late-stage development products at the CMOs including registration stability batches and validation batches successfully resulting in commercial launch.

OTHER QUALIFICATIONS:

• Demonstrated technical project management and/or project leadership experience to develop integrated short-term and long-term project plans
• Ability to work independently in a fast-paced environment
• Extensive experience collaborating with and overseeing CMOs and third party manufacturers
• Experience with process validation is preferable
• Broad knowledge of regulatory (ICH) and cGMP quality requirements for pharmaceutical Product Development
• Experience with authoring and reviewing of the relevant CMC sections of the regulatory submissions
• Exceptional communication, collaboration, and problem-solving skills ensuring alignment with other functions

PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally.
• Visual Acuity - Perform activities such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

CALIFORNIA PAY DATA INFORMATION:
California law requires pay information in job postings. The specific rate will depend on the successful candidate's qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is
$237,500 (entry-level qualifications) to $247,100 (highly experienced).