Scientist 1, Analytical Development

Position Summary 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. Work Schedule Monday-Friday, core hours 8am-4:30pm. 100% on-site (San Diego). Role Perform and train others on a variety of analytical techniques including 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. Interpret data with limited guidance; identify key factors and understand findings; keep accurate record keeping and support secondary review. Increase client interaction; lead discussions with clients on technical topics related to projects. 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. Candidate Bachelor’s of Science degree required plus a minimum of one year of analytical development experience. Master’s of Science acceptable without formal industry experience; preferred to have two years of analytic development experience. 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 GMP manufacturing equipment. Physical requirements: accessible to lab and office staff; vision to read written documents and use computer monitor screen frequently. Pay The anticipated salary range for this role in California is $78,000 to $85,000 annually. Final salary offered may vary based on experience, education, and business needs. Benefits On-site fitness center and company-sponsored events. Environmental initiatives and community engagement beach clean-up activities. Defined career path with annual performance review and feedback process. Employee Resource Groups focusing on diversity and inclusion. Competitive salary with bonus potential; generous 401(k) match and paid time off accrual. Medical, dental, and vision benefits effective day one. 152 hours of PTO plus 10 paid holidays. Tuition reimbursement program. WellHub program for physical wellness. PerkSpot discounts from numerous merchants. Equal Opportunity Employment Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by email, including the job number, title and location to View email address on click.appcast.io. The request will be processed by a U.S. Catalent employee and routed to a local recruiter who will provide assistance. #J-18808-Ljbffr Catalent