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Director, Analytical 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.

Director, Analytical Development Summary

An individual at the level of Director, Analytical Development will be expected to build and lead a team focused on the analysis of small molecule and peptide drug products.  The team will be responsible for supporting early phase development activities such as analytical method transfer, test method development, product testing and phase appropriate validation.  Team members will work closely with both formulation chemists as well as Quality Control. Commonly performed analytical techniques will include HPLC, dissolution (discriminating and USP), UV, Karl Fischer titration, DSC. It is anticipated that the team will include 15-20 people once fully staffed.

The candidate to lead the team must have proven leadership experience in managing and mentoring analytical chemists at various levels. They will be expected to provide strategic input into the team growth plan. They should be independently proficient in a variety of analytical techniques and regulatory areas including, but not necessarily limited to: analytical balances, pH meters, 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. The candidate will be familiar with current statistical techniques used in method development and validation.

The individual will be able to communicate results both internally and externally through oral and written updates and formal reports as necessary.  Opportunities to speak or present at conferences may also arise. Collaboration with Quality Assurance and Quality Control on analytical method validation and compliance issues is expected.  
 

Requirements

  • Requires minimum B.S. in life sciences, ideally Chemistry, Biochemistry, Pharmacological Chemistry or Biology
  • 10+ years’ experience in analytical development in a pharmaceutical setting
  • Proven abilities in leadership and personnel management
  • Knowledge and direct experience with CMC analytical requirements for IND stage drug compounds
  • Able to communicate effectively with clients regarding project scope, scientific results and project updates, including unexpected or negative results and potential delays
  • Strong oral and written communication

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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