Scientist I
Catalent San Diego is hiring for a Scientist in our Analytical Development department who 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. Alternate detection methods such as ELSD may be employed however as well. In addition, the Scientist 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 hand-on laboratory work as well as supervision of multiple direct reports and mentoring/training of other colleagues as needed.
Requirements:
The Role (daily responsibilities)
•Develop stability-indicating methods for peptide and small molecule API and drug products.
•Perform studies to determine if methods are suitable for transfer to Quality Control.
•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), UV/Vis spectroscopy, USP dissolution testing apparatus, moisture analysis by Karl Fischer, disintegration, DSC, TGA, hardness, and friability testing.
•Troubleshoot existing methods internalized to Pharmatek from other vendors.
•Communicate results both internally and externally through oral and written updates and formal reports as necessary.
•Assist in the creation and/or revision of company SOPs.
•Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues
•Hire, train, and supervise analytical group members as necessary
•Other duties may be assigned.
The Candidate (requirements)
•BS degree in a scientific discipline, from an accredited university with 6 – 10 years of experience required in analytical chemistry OR
•MS degree in a scientific discipline, from an accredited university, with 5 – 8 years of experience required in analytical chemistry OR
•PhD degree in a scientific discipline, from an accredited university, with 1 – 3+ years of pharmaceutical industry experience required in analytical chemistry.
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.
About Catalent Pharma Solutions
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied.
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Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.
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.
