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Job Title: Scientist, Analytical Development

City: San Diego

State : CA

JOB DESCRIPTION :

• Develop stability-indicating methods for peptide and small molecule API, intermediates, and drug products from scratch.

• Develop cleaning verification methods

• 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, 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. Supervisor will not need to attend most client meetings.

• 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.

• Collaborate with other departments to troubleshoot technical issues.

• Collaborate with Quality Assurance and Quality Control on analytical method validation and compliance issues. Familiarity with current GMP regulations is required.

• 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.

EDUCATION AND EXPERIENCE : Requires a Ph.D. in Chemistry and 6 months of experience in job offered. 16 course credits related to analytical chemistry and thesis work in the interaction between lipids and biological species can be substituted for 6 months of experience.

SALARY RANGE: $96,762 to $110,160/year

JOB TIME : Full Time

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .