Senior Scientist, Product Development

Senior Scientist, Product Development

Position Summary:

• Work Schedule: Monday-Friday, core hours 8am-4:30pm
• 100% on-site (San Diego)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic.  This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution.  Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds.

This is a very cross-functional position which will lead projects as an individual or build a team focused on oral formulation development for small molecules or peptide drug products and amorphous intermediates. The primary formulation platforms will include tablets, capsules, granules, beads, solutions, suspensions, immediate or 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. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients.

The Role:

• Creates and develops innovative drug formulations using the techniques described above. Has a thorough understanding Good Manufacturing Practice (GMP) and Investigational New Drug (IND-enabling) formulation strategies. Selects and evaluates container/closure systems and storage conditions with limited supervision
• 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. Performs and trains others on a variety of characterization techniques (such as pH, osmolality, viscosity, particle size, DSC, PXRD, SEM, TGA, DVS, powder characterization, dissolution, disintegration, spectrophotometry, and chromatography)
• Independently 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 external manufacturers, or late stage/commercial manufacturing sites within Catalent
• 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 Standard Operating Procedures (SOPs)
• 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
• Hire, train, and supervise formulation group members as necessary.  Develop junior personnel for advancement within the team. Participate in Business Development and Marketing activities by generating scientific expert content, hosting new client visits or teleconferences, and attending conferences or client visits to generate new leads
• Responsible for maintaining a GMP laboratory environment and maintaining a safe, clean laboratory. Suggest and lead continuous improvement projects
• Other duties as assigned

The Candidate:

• 4-year degree (Bachelor’s/B.S.) in a physical, chemical, biological, or pharmaceutical science required plus a minimum of six (6) years of drug product development experience. We will also consider candidates who have a Master of Science (M.S.) with five (5) years’ experience, or PhD with three (3) years of experience in drug product development
• Preferred to have management experience; this person will immediately manage two people with the potential to manage a team of up to 6 in the future
• Preferred to have oral formulation development experience (Tablets, capsules, granulation, spray dried dispersion/amorphous dispersions)
• Strong preference for early phase development (preclinical, phase I-II with new APIs/small molecules), but will