Senior Scientist, Analytical Development

Senior 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, GMP (Good Manufacturing Practices) 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 in San Diego, CA is hiring a Senior Scientist in Analytical Development.  An individual at the level of Senior Scientist, Analytical Development will be expected to either lead projects independently or build a team focused on the development of analytical methods for small molecule, peptide drug products and amorphous intermediates. This individual may be required to have direct reports depending on growth and ability. The focus of this role will be HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, and chiral. In addition, the individual may be responsible for overseeing development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products. The Senior Scientist, Analytical Development will be required to assist QC/QA in investigations as an SME. All duties will be performed in compliance with company standard operating procedures (SOPs) and GMP (Good Manufacturing Practices) regulations, as appropriate.

This is a full-time salaried position Monday-Friday on 1st shift (day shift) with flexibility.

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:

• Develop stability-indicating methods for peptide and small molecule API (Active Pharmaceutical Ingredient), amorphous intermediates, and drug products from scratch. Develop cleaning verification methods.
• 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), UV/Vis spectroscopy, GC (gas chromatography), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, PXRD (X-ray diffraction), DSC (Differential scanning calorimetry), FT-IR (infrared spectroscopy), TGA (thermogravimetric), and SEM (scanning electron microscopy), hardness, and friability testing.
• Troubleshoot and optimize analytical methods for characterization of drug products and intermediates. Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues’ work for scientific accuracy and compliance. Responsible for transfer of analytical methods to other sites as required. Collaboration with other departments to troubleshoot technical issues.
• Communicate results both internally and externally through oral and written updates and formal reports as necessary.  Organize meetings and monitor all client interactions independently.  Supervisor will be notified if their assistance is needed.
• Assist in the creation and/or revision of new department-wide and site-wide procedures and company SOPs. Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues.
• Individuals will stay abreast of current scientific technologies to maintain the state-of-the-art nature of Catalent’s services. Individuals will proactively communicate strategy to clients