Scientist 3, Analytical Development

Scientist 3, Analytical DevelopmentPosition Summary:Work Schedule:Monday-Friday, core hours 8am-4:30pm100% 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 includepreformulationtesting, formulation and analytical development, cGMPmanufacturingand 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 Scientist3 in our Analytical Development group will lead analytical method development projects for small molecule, peptide, and amorphous drug products, with a strong focus on HPLC/UPLC stability-indicating methods, while ensuring GMP compliance and supporting analytical strategy, troubleshooting, and continuous improvement initiatives. The role combines hands-on laboratory work with potential supervision and mentoring responsibilities, as well as collaboration with QA/QC, customers, and cross-functional teams.
The Role:Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug products from scratch. Develops 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, USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, Pion µdiss, DSC, TGA, PSD, PXRD, SEM, hardness, and friability testing.
Troubleshoot and optimize analytical methods for characterization of drug products and intermediatesPerform qualification studies to determine if methods are suitable for transfer to Quality Control.
Communicate results both internally and externally through oral and written updates and formal reports as necessary. Lead discussions with clients on technical topics relating to their project. Supervisor will not need to attend most client meetings.
Exercise technical discretion and critical thinking in the design, execution and interpretation of experiments independently with minimal supervisor assistance. Data interpretation should be conducted independently.
Assist in the creation and/or revision of new department-wide and site-wide procedures and company SOPs.
Clear and accurate record keeping in laboratory notebooks and secondary review of other colleagues’ work for scientific accuracy and compliance.
Collaboration with other departments to troubleshoot technical 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 and work with their supervisor or BD to generate new proposals or change orders, as appropriate. Individuals will support the business aspects of their position by working with their supervisor to perform billing communication for all work proposals under their supervision.
Opportunity to hire, train and supervise 1-2 full time analytical group members and lab assistantsOther duties as assigned.
The Candidate:4 year degree in a physical, chemical, biological, or pharmaceutical science requiredBS with 4+ years of experience required in analytical development.
MS with 3+ years of experience required in analytical development.
PhD with 1+ years of experience required in analytical development.
Physical

Requirements:
Individual needs to be accessible tolaband office staff andableto use required office equipment. Specific vision requirements include reading of written documents and use of computermonitorscreenfrequentlyPay:Theanticipatedsalary range for this role in California is $115,000 to $125,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limitedto:the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.  Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why you should join Catalent: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 encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
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