Principal Scientist, Product Development

Principal Scientist, Product Development

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, Good Manufacturing Practices (GMP) manufacturing and stability storage and testing as well as Clinical Supply Services.  At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

Catalent Pharma Solutions is hiring a Principal Scientist for Product Development at our San Diego, CA site. An individual at the level of Principal Scientist, Product Development will lead projects as an individual or build a team focused on oral formulation development for small molecule or peptide drug products and amorphous intermediates. This individual may be required to have direct reports depending on growth and ability. The primary formulation platforms will include tablets, capsules, granules, beads, solutions, suspensions, immediate release and extended-release dosage forms, and amorphous intermediates.  The individual will research and introduce new formulation technology to produce and characterize drug products and will be the primary point of customer contact for formulation strategy, compliance, and troubleshooting. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.

This is a full-time position: Monday – Friday, 8am-5pm on-site with flexibility for periodic remote/hybrid work.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Creates and develops innovative drug formulations and has depth of experience in one or more of the techniques described above. Performs and trains others on a variety of formulation techniques including, but not necessarily limited to: blending, encapsulation, suspensions, solutions, wet/dry/fluid bed granulation, tablet compression, coating, milling, spray drying
• Responsible for the successful transfer of formulation projects to the GMP manufacturing team and for collaboration with process engineering team during technology transfer. Responsible for transfer of projects to late stage or commercial manufacturing sites
• Communicates results both internally and externally through oral and written updates and formal reports as necessary.  Organize meetings and monitor all client interactions independently. Participate in and lead cross-functional teams. Performs secondary review of other colleagues’ work for scientific accuracy and compliance. Creates and/or revises new department-wide and site-site procedures and company SOPs 
• Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent’s services and will evaluate new technologies to expand our technical service offering. Individuals will proactively communicate strategy to clients and draft addendums to contracts and write and provide review of new proposals and change orders, as appropriate
• Individuals will support the business aspects of their position by taking responsibility for the execution and billing communication for all work proposals under their supervision. Lead and train others on Continuous Improvement (CI) and innovation projects
• Hire, train, and supervise formulation group members as necessary.  Develop junior personnel for advancement within the team. Responsible for maintaining a GMP laboratory environment
• Participate in business development and marketing activities by generating scientific exp