Senior Scientist, Analytical Development, Manager About SiteCatalent'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.
Position SummaryWe 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.
Shift: Monday-Friday 8 AM - 5 PM
Location: San Diego, CA
100% Onsite
The Role- 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.
The CandidateMinimum 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.
PayThe anticipated salary range for this position in CA is $135,000 - $140,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: 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- Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
- Competitive Paid Time Off plus 10 paid holidays.
- Medical, dental and vision benefits effective day one of employment.
- Tuition Reimbursement - support to finish your degree or earn a new one.
- Site-based Employee Engagement activities such as Movie Day, Annual Blues Fest, Free Bagel Fridays and more.
- 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.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
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