Supervisor, Manufacturing Sciences & Technology

Catalent Pharma Solutions•Kansas City, MO

8d•Onsite

About The Position

The Kansas City Clinical Development & Supply Floor Manufacturing Sciences and Technology Supervisor will develop and lead a group, including the transfer between external clients and Manufacturing. The supervisor is responsible for leading the team of strong engineers, scientists, or qualified person to be technology transfer process owner to deliver excellent services to internal and external customers. This role is a strategic client-facing leader of the MS&T team on the behalf of the organization. Works cross functionally with project managers, manufacturing, label design and control, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility. Participates and leads commercial manufacturing transition and support for process development. Enhance productivity by exploring, analyzing, facilitating, and leveraging efficiency initiatives for packaging processes through The Catalent Way. Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements. Bridge the focus areas of Project Management, Operations, Quality, EHS, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless packaging. Leads the compilation of process data, including communicating project status, and delivering internal and client presentations. Collects and trend process data for external (Clients) and internal review to ensure process consistency. Provides business case for process improvement projects.

Requirements

Bachelor's degree in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, OR a HS Diploma/GED and 4+ years of relevant experience required.
Experience with Upstream and Downstream processes of cGMP clinical packaging.
Project management experience/skills required including method transfers, and risk assessment.
Knowledge of regulatory, validation and documentation requirements for product development, commercial production, and site transfers.
Experience in investigating and closing out deviations, OOS, CAPAs, and change controls.
Knowledge of thermoforming/cold-forming equipment is required.
A good working knowledge of Microsoft Office (Word, PowerPoint, Excel and Visio) and TOPS Pro (Total Optimization Packaging System) or similar software program.
Ability to learn and use software packages (e.g. TrackWise®, ComplianceWire®).
Demonstrated strong working knowledge of Tech Transfer (Internal and External).
Understanding and application of Risk Assessment tools (Hazard Analysis, FMEA, etc.).

Nice To Haves

Experience working on late phase and commercial programs is a plus.

Responsibilities

Develop and lead a group, including the transfer between external clients and Manufacturing.
Lead the team of strong engineers, scientists, or qualified person to be technology transfer process owner to deliver excellent services to internal and external customers.
Act as a strategic client-facing leader of the MS&T team on the behalf of the organization.
Work cross functionally with project managers, manufacturing, label design and control, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility.
Participate and lead commercial manufacturing transition and support for process development.
Enhance productivity by exploring, analyzing, facilitating, and leveraging efficiency initiatives for packaging processes through The Catalent Way.
Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements.
Bridge the focus areas of Project Management, Operations, Quality, EHS, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless packaging.
Lead the compilation of process data, including communicating project status, and delivering internal and client presentations.
Collect and trend process data for external (Clients) and internal review to ensure process consistency.
Provide business case for process improvement projects.
Perform other duties assigned.