Scientist 3, Analytical Development

Catalent • San Diego, CA

7d • $115,000 - $125,000 • Onsite

About The Position

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 3 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.

Requirements

• 4 year degree in a physical, chemical, biological, or pharmaceutical science required
• BS 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.
• 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

Responsibilities

• 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 intermediates.
• Perform 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.
• 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.
• Stay abreast of current scientific technologies to maintain the state of the art nature of Catalent’s services.
• Proactively communicate strategy to clients and work with their supervisor or BD to generate new proposals or change orders, as appropriate.
• 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 assistants.
• Other duties as assigned.

Benefits

• Competitive salary with bonus potential.
• Generous 401K match and Paid Time Off accrual.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement
• WellHub program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior