Manager, Technical Services

Manager, Technical Services

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This is a full-time, salaried position located at our Kansas City, MO site.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.  The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and roller compaction.

The Kansas City facility is also a Center-of-Excellence for our Biologics Analytical Services business. Our large molecule analytical team has over 25 years of experience providing broad-based and orthogonal analytical CMC services for stand-alone and integrated biologics projects.  We provide support for drug substance, drug product, and intermediates for both innovator and biosimilar/biobetter products.

Our facility also offers comprehensive clinical packaging services including clinical supply management, package engineering, clinical manufacturing, primary and secondary packaging, global distribution and logistics, and return/destruction services. The facility features an isolated potent suite and DEA Schedule I-V controlled drug storage to handle even your most challenging products.

The Manager, Technical Services leads the activities of the Technical Services group. The Technical Services group’s function is to prepare the Production operation to execute Label Printing and Primary and Secondary Packaging. The Manager, Technical Services utilizes knowledge of the packaging industry and clinical experience to provide processes and systems that operate in an effective manner to positively impact the SQDC of the business.

As the first line interface with Project Management and Catalent’s customers, this group provides the technical expertise required to efficiently design, onboard, and execute Packaging and Distribution programs that affect the health and well-being of patients involved in clinical trials or receiving commercially available medication. The Manager, Technical Services is also closely tied in with the Business Development and Client Services teams, working closely to define proposals that highlight the strengths of the packaging site. Primary and Secondary Package designs are completed, and tooling is procured and designed to support the package designs. In addition, the manager will oversee package engineering, maintenance, operation support activities, and operations compliance specialists.
 

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Sets priorities for the group to ensure task completion and coordinates activities with other departments to ensure provision of batch records and components and priorities to address resource or operational challenges

• Provides advanced technical and operational guidance to employees, colleagues, and customers

• Provides insight and guidance into event Root Cause Analysis (including Safety, Quality and Delivery events) and reviews/approves reports (i.e. discrepancies, deviations, and complaints)

• Responsible for the performance and results of the Technical Services group as outlined below

• Accountable for the overall quality of output produced by the Technical Services group, including batch records and specifications

• Provides oversight and assistance with investigations related to Technical Services (discrepancies, deviations, and complaints) as well as Corrective and Preventat