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Scientist, Analytical Methods Development

About Catalent San Diego

Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing.

At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.

Scientist, Analytical Methods Development

An individual at the level of Scientist, Analytical Methods Development will be expected to build and lead a team focused on the development of analytical methods for small molecule and peptide drug products.  The main focus will be HPLC/UPLC-UV stability-indicating methods using various separation chemistries including but not limited to reversed phase, ion-exchange, and chiral.  However alternate detection methods such as ELSD may be employed.  In addition, the individual may be responsible overseeing development of assay, dissolution, water content, and physical characterization methods for oral and injectable drug products.  The individual will assist in the researching and introduction of new analytical technology to characterize drug products. There is an expectation of both direct hands-on laboratory work as well as supervision of 1-3 direct reports and mentoring/training of other colleagues as needed.

They must be independently proficient in a variety of analytical techniques and regulatory areas including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC), UV/Vis spectroscopy, USP dissolution testing apparatus, moisture analysis by Karl Fischer, and analytical method validation.  Experience with disintegration, DSC, TGA, hardness, and friability testing also desired. Methods that are developed within the group will be qualified or validated as appropriate for the stage of development.  In addition, the individual may assist in troubleshooting existing methods internalized to Pharmatek from other vendors.

The individual will be able to communicate results both internally and externally through oral and written updates and formal reports as necessary.  The individual may be required to assist in the creation and/or revision of company SOPs.  Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues is expected.

Requirements

  • Requires B.S. in life sciences, ideally Chemistry, Biochemistry, Pharmacological Chemistry or Biology
  • 7+ years’ experience in analytical development
  • Thorough knowledge and experience in HPLC stability-indicating method development and validation
  • Strong oral and written communication
  • Previous supervisory experience preferred

About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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

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