Scientist , Analytical Development

Overview

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). 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 services that support oral and injectable dosage forms including preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds.

Work Schedule:

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

• Perform and train others on a variety of analytical techniques including, but not limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, Gas Chromatography (GC), USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing
• Develop cleaning verification methods and execution of excipient compatibility and forced degradation studies, under supervision
• Troubleshoot and optimize analytical methods for characterization of drug products and intermediates
• Perform qualification studies to determine if methods are suitable for transfer to Quality Control. Simple experimental design and execution will be performed independently. Complex design may need supervisor assistance
• Data interpretation should be conducted with limited guidance. Identify key factors from data and understand the importance of the findings. Maintain clear and accurate record keeping in laboratory notebooks and provide secondary review of other colleagues’ work for scientific accuracy and compliance
• Increase in client interaction will be a focus. May lead discussions with clients on technical topics relating to their project
• Have a good general foundation of scientific principles, chemistry concepts, and proficiency in core analytical scientific techniques, GMPs, and technical writing
• Other duties as assigned

• Bachelor’s of Science degree is required plus a minimum of one (1) year of analytical development experience
• Master’s of Science may be considered with no formal industry experience, but two (2) years of experience in analytical development is highly preferred
• Demonstrated proficiency in the qualification of analytical test methods for API, intermediates, and final drug products, particularly HPLC and UPLC stability-indicating assays, GC, dissolution methods, and water content methods. Experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM. Responsible for developing product-specific cleaning methods to support use of GMP manufacturing equipment
• Physical Requirements:
  
  able to access lab and office environments and use required office equipment. Specific vision requirements include reading written documents and using a computer monitor frequently

• The anticipated salary range for this role in California is $78,000 to $85,000 annually. The final salary offered to a successful candidate may vary and will be dependent on factors including type and length of experience, skillset, education, and business needs. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

• Awesome employee activities:
  Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourage positive employee camaraderie and a positive work environment.
• Environmentally friendly green initiatives with on-site practices and participation in Beach Clean-up activities for community engagement.
• Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Several Employee Resource Groups focusing on Diversity and Inclusion.
• Comp…