Scientist , Analytical Development

Scientist 1, Analytical 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.

The Scientist 1 in our Analytical Development group will independently plan and execute simple laboratory experiments and clearly communicate the status of projects to cross-functional team members, management, and clients. This individual will support the qualification of analytical test methods for Active Pharmaceutical Ingredients (API), intermediates, and final drug products using a variety of chromatography techniques (H/UPLC, GC), physical characterization techniques (TGA, DSC, PXRD, GVS, SEM) and dissolution/water content methods.

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.

• 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, 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. Individuals will be able to identify key factors from data and understand the importance of the findings. Clear and accurate record keeping in laboratory notebooks and some secondary review of other colleagues’ work for scientific accuracy and compliance

• Increase in client interaction will be a focus. Individuals may lead discussions with clients on technical topics relating to their project

• Individuals should have a good general foundation of scientific principles, chemistry concepts, and be proficient 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

• We will also accept a Master’s of Science without any formal industry experience, but highly preferred to have two (2) years of analytical development

• The individual must have 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. The individual should also have experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM. The individual will be responsible for developing product-specific cleaning methods to support use of GMP manufacturing equipment

• Physical Requirements:
  
  Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen 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…