Catalent, Inc.
Contract Development and Manufacturing Organization (CDMO)
Sr.Manager,AnalyticalQualityControl
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. Manager, Analytical Quality Control at Catalent, Inc.. Skills: Analytical Quality Control, Managerial experience, GMP experience. Maintaining an internal QC sub-group of chemists. Oversight of ancillary functions within the QC team”
Industry & Context.
data interpretation; propose follow up experiments; method and instrument trouble shooting
100% on-site (San Diego), Individual needs to be accessible to lab and office staff and able to use required office equipment, Specific vision requirements include reading of written documents and use of computer monitor screen frequently
What They're Looking For.
Must Have
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, 3+ years of GMP experience required
Nice to Have
5+ years of managerial experience, history of managing tiered groups preferred
What You'll Do.
Maintaining an internal QC sub-group of chemists
Oversight of ancillary functions within the QC team
Direct supervision of QC chemists
including managerial responsibilities such as development plans
and performance reviews
Managing client communication (written and oral) for all applicable projects maintained by direct reports and as part of functional role
Providing guidance on the creation of deviations and OOS investigations
Supporting or leading QCA within or across departments
Lead data interpretation and use conclusions to propose follow up experiments
Expertise in the use of analytical instrumentation and application of technical guidance to junior analysts on method and instrument trouble shooting
Support Continuous Improvement initiatives within the QC group
Identifying areas of potential improvement and leading projects
Provide feedback on efficiency initiatives performed in the department
Assist in finding ways to improve fiscal responsibility for hiring
and workload distribution
How You'll Work.
Team & Collaboration
Maintain excellent communication with the QC department head as well as the heads of other departments; Supporting or leading QCA within or across departments
Communication Scope
client communication (written and oral); communicating issues to department head
Process & Methodology
leading projects
Full Job Description
**Sr. Manager, Analytical Quality Control** **Position Summary:** * **Work Schedule:** Monday-Friday, core hours 8am-4:30pm * 100% on-site (San Diego) 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. **The Role:** * 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
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