Catalent, Inc.

Contract Development and Manufacturing Organization (CDMO)

Sr.Manager,AnalyticalQualityControl

$150–162k San Diego, California, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Contract Development and Manufacturing Organization (CDMO)
Problems you'll solve

data interpretation; propose follow up experiments; method and instrument trouble shooting

Eligibility Requirements

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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