Associate Scientist, Analytical Development

Associate Scientist, Analytical 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 an Associate Scientist, Analytical Development for our San Diego, CA team. This is a great opportunity to gain hands-on industry experience and learn a variety of lab techniques. The Associate Scientist will be expected to understand and execute basic analytical procedures in order to assess the quality of pharmaceutical API (active pharmaceutical ingredient), intermediates, and final drug products under limited supervision. Duties may include the preparation of simple aqueous and organic buffered solutions, volumetric dilution of samples and standards using good laboratory techniques, clear and accurate record keeping in laboratory notebooks, use of analytical instrumentation to acquire raw data, calculation and reporting of final results. The Associate Scientist will begin to develop product-specific cleaning methods to support use of GMP manufacturing equipment.  All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP regulations, as appropriate.

This is a full-time hourly position: Monday – Friday, 8am-5pm on-site.

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:

• Perform and train others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), GC (gas chromatography), DSC (Differential scanning calorimetry), TGA (thermogravimetric), PXRD (X-ray diffraction), SEM (scanning electron microscopy), GVS, UV/Vis spectroscopy, USP dissolution testing apparatus, disintegration, hardness, friability, and moisture analysis by Karl Fischer
• Conduct prototype stability studies to support future formulation efforts. Perform cleaning method development and solid state characterization techniques
• Troubleshoot and refine analytical methods for characterization of drug products and intermediates. Experimental design and execution will be under a supervisor’s direction
• Clear and accurate record keeping in laboratory notebooks and some secondary review of other colleagues’ work for scientific accuracy and compliance, as assigned by supervisor
• Maintain a high level of professional expertise through familiarity with scientific literature. Training on scientific techniques, GMPs, and ICH guidance is emphasized
• Limited training of other team members and client interaction will be supported by supervisor
• Other duties as assigned

The Candidate:

• Bachelor’s in a physical, chemical, biological, or pharmaceutical science is required
• No experience required in analytical development, but the candidate must have some formal lab training
• Candidate must also be highly detail-oriented and organized, able to work both independently and as a team player with a positive attitude. Must demonstrate excellent communication, critical thinking, and organizational skills
• Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with