Senior Manufacturing Product Lead

Catalent Pharma Solutions•Kansas City, MO

2d•Onsite

About The Position

Senior Manufacturing Product Lead Position Summary Work Schedule: first shift, Monday to Friday 100% on-site in Kansas City Catalent’s Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions—from science and engineering to operations and logistics. The Senior Manufacturing Product Lead is responsible for providing technical support for oral solid dose (OSD) process manufacturing (tablets/capsules) including process improvements, tech transfer, process investigations, and process troubleshooting. Serves as a Subject Matter Expert (SME) for multiple processing operations and provides technical leadership for commercial product processes. The Role Collaborates cross-functionally with Manufacturing, Engineering, Maintenance, EHS and Quality to optimize productivity, safety, product quality and supply reliability for commercial products in compliance with cGMPs. Ensures commercial drug product manufacturing is Ready to Execute (RTE): Authors, reviews and approves commercial product manufacturing master batch records, BOMs, equipment recipes and cleaning verification forms as necessary to ensure RTE reliability. Partner with commercial clients as required on technical issues affecting their drug product(s). Act as product technical steward on client interactions. Provides technical support for process manufacturing areas, including investigation and correction of product/process-related problems and deviations, process troubleshooting and improvements. Serves as a subject matter expert during internal audits and regulatory inspections for technical aspects of the drug product process. Responsible for identifying, executing and implementing continuous improvement projects to reduce product cost, improve product quality, improve process safety and simplify processes to improve compliance. Initiates process manufacturing area change proposals as required. Supports Manufacturing aspects of annual product reviews, continued process verification, product/process risk assessments, FMEAs, etc. Minimum of 25% shop floor/unit operation presence is required to successfully support manufacturing. Leads technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites, into the Kansas City facility or out to other Catalent sites, as well as between clinical and commercial manufacturing. Train and mentor manufacturing product leads and help train manufacturing colleagues on product/processes and equipment technology as required. All other duties as assigned

Requirements

Bachelor of Science degree required; preferably in engineering, science or other related technical discipline.
7+ years experience in OSD pharmaceutical operations is required.
Excellent verbal, written, and interpersonal communication skills are essential as this is a client-facing role.
Understanding of cGMPs, demonstrated leadership, management and technical capabilities preferred.
Must have demonstrated ability to organize and implement projects that improve the operational effectiveness of product manufacturing.
Proficient in Microsoft Office Tools

Nice To Haves

Prefer experience in pharmaceutical production and process engineering.
Experience in Lean Manufacturing/OpEx and Six Sigma is desired.

Responsibilities

Provides technical support for oral solid dose (OSD) process manufacturing (tablets/capsules) including process improvements, tech transfer, process investigations, and process troubleshooting.
Collaborates cross-functionally with Manufacturing, Engineering, Maintenance, EHS and Quality to optimize productivity, safety, product quality and supply reliability for commercial products in compliance with cGMPs.
Ensures commercial drug product manufacturing is Ready to Execute (RTE): Authors, reviews and approves commercial product manufacturing master batch records, BOMs, equipment recipes and cleaning verification forms as necessary to ensure RTE reliability.
Partner with commercial clients as required on technical issues affecting their drug product(s). Act as product technical steward on client interactions.
Provides technical support for process manufacturing areas, including investigation and correction of product/process-related problems and deviations, process troubleshooting and improvements.
Serves as a subject matter expert during internal audits and regulatory inspections for technical aspects of the drug product process.
Responsible for identifying, executing and implementing continuous improvement projects to reduce product cost, improve product quality, improve process safety and simplify processes to improve compliance.
Initiates process manufacturing area change proposals as required.
Supports Manufacturing aspects of annual product reviews, continued process verification, product/process risk assessments, FMEAs, etc.
Minimum of 25% shop floor/unit operation presence is required to successfully support manufacturing.
Leads technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites, into the Kansas City facility or out to other Catalent sites, as well as between clinical and commercial manufacturing.
Train and mentor manufacturing product leads and help train manufacturing colleagues on product/processes and equipment technology as required.
All other duties as assigned