Catalent San Diego is looking to hire a Director of Analytical Development to build and lead a team focused on the analysis of small molecule and peptide drug products. The Analytical Development team will be responsible for supporting early phase development activities such as analytical method transfer, test method development, product testing and phase appropriate validation. As a key member of the Senior Leadership team, the Director will drive to meet objectives efficiently and on time, in a fast-paced environment, by providing strategic direction, technical expertise, and tactical oversight for all activities in Analytical Development.
The Role (daily responsibilities)
- Leads the Analytical Development and Pre-formulation team in the technical execution of defined analytical strategies supporting site initiatives and projects. It is anticipated that the team will include 15-20 people once fully staffed.
- Provides coaching, training and mentorship to his/her direct reports and other scientists within the Analytical Development department.
- Administers performance management program and provides strategic input into the team growth plan.
- Oversight of the AD team's core function which may include reviewing analytical technical data using techniques including HPLC, dissolution (discriminating and USP), UV, Karl Fischer titration, DSC.
- Communicates results regularly to both internal and external audiences through oral and written updates and formal reports as necessary. Opportunities to speak or present at conferences may also arise.
- Collaborates with Quality Assurance and Quality Control on analytical method validation and compliance issues to ensure that high quality standards are maintained and the appropriate documentation is completed.
- Supports operational budgets, cost controls and resource planning to meet corporate strategic objectives.
- Fosters a culture of high performance and excellence in everything we do.
The Candidate (requirements)
- Requires minimum Bachelor's degree, from an accredited university, in a scientific discipline (ideally in Chemistry, Biochemistry, Pharmacological Chemistry or Biology).
- 10+ years’ experience in analytical development. Small Molecule, Early Phase, Solid Oral Dosage product focus experience is highly desired.
- Proven abilities in leadership and personnel management.
- Requires technical depth in a broad spectrum 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 AD group will be qualified or validated as appropriate for the stage of development. The successful candidate will be familiar with current statistical techniques used in method development and validation.
- Knowledge and direct experience with CMC analytical requirements for IND stage drug compounds.
- Expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive).
- Excellent verbal & written communication skills, with the ability to effectively present to and influence different functional groups across all levels of the organization.
- Able to communicate effectively with clients regarding project scope, scientific results and project updates, including unexpected or negative results and potential delays.
- Desire to be a part of a highly innovative company with a focus on Patient First values.
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.™
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 [Click Here to Email Your Resumé]. 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.