Scientist 3, Analytical Development

About the role

The Scientist 3 in our Analytical Development group will lead analytical method development projects for small molecule, peptide, and amorphous drug products, with a strong focus on HPLC/UPLC stability-indicating methods, while ensuring GMP compliance and supporting analytical strategy, troubleshooting, and continuous improvement initiatives.

Responsibilities

• Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug products from scratch.
• Develops cleaning verification methods.
• Performs and trains 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, 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.
• 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.
• Aid 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.
• Collaborate with other departments to troubleshoot technical issues.
• Stay abreast of current scientific technologies to maintain the state of the art nature of Catalent's services.
• Proactively communicate strategy to clients and work with their supervisor or BD to generate new proposals or change orders, as appropriate.
• Support the business aspects of their position by working with their supervisor to perform billing communication for all work proposals under their supervision.
• Opportunity to hire, train and supervise 1-2 full time analytical group members and lab assistants.

Qualifications

• 4 year degree in a physical, chemical, biological, or pharmaceutical science required.
• BS with 4+ years of experience required in analytical development.
• MS with 3+ years of experience required in analytical development.
• PhD with 1+ years of experience required in analytical development.

Skills

• Strong analytical skills.
• Experience with HPLC/UPLC, GC, UV/Vis spectroscopy, and other analytical techniques.
• Ability to troubleshoot and optimize analytical methods.
• Excellent communication and interpersonal skills.
• Proficient in data interpretation and reporting.
• Ability to work independently and collaboratively.

Benefits

Not specified.

Pay

The anticipated salary range for this role in California is $115,000 to $125,000 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.

Schedule

Monday-Friday, core hours 8am-4:30pm

Location

100% on-site (San Diego)

Contact

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.