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Catalent · 2 days ago

Scientist 3, Analytical Development

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$117K/yr - $130K/yr

3+ years exp

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. The Scientist 3 in our Analytical Development group will independently lead projects, primarily supporting the development of analytical methods for small molecules and peptides.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

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

Qualification

Analytical developmentHPLC/UPLC methodsGMP regulationsGas Chromatography (GC)Physical characterization techniquesCommunication skillsTeam leadershipCritical thinking

Required

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

Develop cleaning verification methods and stability-indicating methods for peptide and small molecule Active Pharmaceutical Ingredients (API), intermediates, and drug products from scratch

Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues, and collaborate with other departments to troubleshoot technical issues

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

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

Preferred

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

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.

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)