Scientist 3, Analytical Development

Catalent Pharma Solutions•San Diego, CA

7d•$117,000 - $130,000•Onsite

About The Position

Scientist 3, Analytical Development Position Summary: Work Schedule: Monday-Friday, core hours 8am-4:30pm 100% 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 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 independently lead projects under minimal supervision and potentially supervise 1-2 team members. This individual will primarily support development of analytical methods for small molecules, peptides, and amorphous intermediates with a focus in H/UPLC-UV stability indicating methods (reverse phase, ion-exchange, chiral). You will also support the development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products and amorphous intermediates. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: Develop cleaning verification methods and stability-indicating methods for peptide and small molecule Active Pharmaceutical Ingredients (API), intermediates, and drug products from scratch 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, Gas Chromatography (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. Independently 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 Quality Assurance and Quality Control on analytical method validation and compliance issues, and collaborate with other departments to troubleshoot technical issues. Familiarity with current GMP regulations is required 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 Business Development to generate new proposals or change orders. 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 Other duties as assigned

Requirements

Bachelor’s of Science degree is required plus a minimum of four (4) years of analytical development experience
We will also accept a Master’s of Science plus a minimum of three (3) years of analytical development experience OR a PhD with at least one (1) year of analytical development experience
Familiarity with current GMP regulations
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

Nice To Haves

The preferred candidate will have 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.
The individual should also have experience in physical characterization techniques such as TGA, DSC, PXRD, GVS, and SEM.
The individual will be responsible for developing product-specific cleaning methods to support use of GMP manufacturing equipment

Responsibilities

Develop cleaning verification methods and stability-indicating methods for peptide and small molecule Active Pharmaceutical Ingredients (API), intermediates, and drug products from scratch
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, Gas Chromatography (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.
Independently 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 Quality Assurance and Quality Control on analytical method validation and compliance issues, and collaborate with other departments to troubleshoot technical issues.
Familiarity with current GMP regulations is required
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 Business Development to generate new proposals or change orders.
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
Other duties as assigned

Benefits

Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, 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.
Defined career path and annual performance review and feedback process.
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Several Employee Resource Groups focusing on Diversity and Inclusion.
Competitive salary with bonus potential.
Generous 401K match and Paid Time Off accrual.
Medical, dental and vision benefits effective day one of employment.
152 hours of PTO + 10 paid holidays.
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
WellHub program to promote overall physical wellness.
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