Senior Scientist, Analytical Development, Manager

Catalent • San Diego, CA

21h • Onsite

About The Position

Catalent’s San Diego, CA site is an early‑phase development facility supporting small‑molecule and peptide programs from preformulation through cGMP clinical manufacturing for oral and injectable dosage forms. The 68,000‑square‑foot site is a center of excellence for spray‑drying and bioavailability‑enhancement technologies, with integrated capabilities to advance challenging compounds rapidly into the clinic. We have an opportunity for a Senior Scientist, Analytical Development, Manager to join our team. In this role, you will lead projects or manage a team focused on developing analytical methods for small molecule and peptide drug products. You will work with advanced techniques such as HPLC/UPLC-UV and other detection methods, ensuring compliance and scientific accuracy. This position offers the chance to make a direct impact on patient outcomes by improving the quality and efficacy of drug products.

Requirements

• Bachelor’s degree in a physical, chemical, biological, or pharmaceutical science required.
• Bachelor’s degree with 6+ years of experience in analytical development.
• Master’s degree with 5+ years of experience in analytical development.
• Doctorate degree with 3+ years of experience in analytical development.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
• On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 25 pounds.
• Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently.

Responsibilities

• Develop stability-indicating methods for peptide and small molecule API, amorphous intermediates, and drug products from scratch.
• Develop cleaning verification methods.
• Perform and train others on 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, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), particle size distribution (PSD), powder X-ray diffraction (PXRD), scanning electron microscopy (SEM), hardness, and friability testing.
• Troubleshoot and optimize analytical methods for characterization of drug products and intermediates.
• Maintain clear and accurate record keeping in laboratory notebooks and review colleagues’ work for scientific accuracy and compliance.
• Transfer analytical methods to other sites as required.
• Collaborate with other departments to troubleshoot technical issues.
• Communicate results internally and externally through updates and formal reports.
• Organize meetings and manage client interactions independently.
• Assist in creating and revising department-wide and site-wide procedures and company standard operating procedures (SOPs).
• Collaborate with Quality Assurance and Quality Control on analytical method validation and compliance issues.
• Stay current with scientific technologies to maintain state-of-the-art services.
• Communicate strategy to clients and draft addendums to contracts, proposals, and change orders as appropriate.
• Support business aspects by managing execution and billing communication for work proposals under supervision.
• Hire, train, and supervise analytical group members.
• Develop junior personnel for advancement within the team.
• Suggest and lead continuous improvement projects.
• Comply with good housekeeping and safety practices.

Benefits

• Competitive Paid Time Off plus 10 paid holidays.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly, community engagement green initiatives including regularly participating in Beach Clean-up.
• Defined career path and annual performance review and feedback process with potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• WellHub program to promote overall physical wellness including onsite fitness center, yoga classes and company sponsored community sports teams.
• 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