Sr. Manager, Analytical Quality Control

Catalent • San Diego, CA

2d • Onsite

About The Position

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds. The Sr. Manager, Analytical Quality Control is responsible for maintaining an internal QC sub-group of chemists, which may include tiered management responsibilities as well as oversight of ancillary functions within the QC team. They must demonstrate flexibility, leadership and adaptability to the ever-changing demands of the department and maintain excellent communication with the QC department head as well as the heads of other departments.

Requirements

• BS or MS degree in Chemistry or other applicable scientific discipline required.
• 12+ years of applicable industry experience in either Analytical Development or Quality Control required.
• 6+ years of applicable laboratory experience and technical expertise on analytical procedures and all generated data required.
• 5+ years of managerial experience, history of managing tiered groups preferred
• 3+ years of GMP experience required.

Responsibilities

• Direct supervision of QC chemists, including managerial responsibilities such as development plans, goal setting, and performance reviews.
• Managing client communication (written and oral) for all applicable projects maintained by direct reports and as part of functional role, including the handling of issues or sensitive subjects that arise.
• Providing guidance on the creation of deviations and OOS investigations to members of own team as well as other chemists/supervisors/managers.
• Supporting or leading QCA within or across departments.
• Lead data interpretation and use conclusions to propose follow up experiments, as necessary, for Out of Specification investigations and deviations.
• Expertise in the use of analytical instrumentation and application of technical guidance to junior analysts on method and instrument trouble shooting and communicating issues to department head.
• Support Continuous Improvement initiatives within the QC group, identifying areas of potential approvement and leading projects, where applicable
• Will provide feedback on efficiency initiatives performed in the department, and assist in finding ways to improve fiscal responsibility for hiring, resource allocation, and workload distribution.
• Other duties as assigned

Benefits

• Competitive salary with bonus potential.
• Generous 401K match and Paid Time Off accrual.
• Medical, dental and vision benefits effective day one of employment.
• 152 hours of PTO + 10 paid holidays.
• Tuition Reimbursement
• WellHub program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager