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

The Candidate:

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
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
Physical Requirements: 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

Pay:

The anticipated salary range for this role in California is $117,000 to $130,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not 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:

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.
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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.