Position Title Manufacturing Product Lead
The 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.
- Provides technical support for process manufacturing areas, including investigation and correction of product/process-related problems and deviations, process troubleshooting and improvements.
- Enhance quality and effectiveness of manufacturing systems related to existing commercial products.
- Supports the design, execution and evaluation of experimental plans to ascertain the required process capabilities, specifications and robustness.
- 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.
- Collaborates cross-functionally with Manufacturing, Engineering, Automation, Maintenance, EHS and Quality to optimize productivity, safety, product quality and compliance, and supply reliability.
- 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.
- Updates, reviews, and approves area procedures as assigned to assure correct content and compliance with Good Manufacturing Practices.
- Responsible for providing pharmaceutical process support to new and existing OSD products/processes.
- 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. Initiates process manufacturing area change proposals as required for assigned projects or in support of Manufacturing.
- Help train and mentor manufacturing colleagues on product/processes and equipment technology as required.
- Develop Product/Process knowledge in multiple product streams and technologies.
- Partner with commercial clients as required on technical issues affecting their drug product(s).
- Act as product technical steward on client interactions. Reviews, approves and participates in qualification and validation activities.
- 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 and therefore meet expectations for this position.
- Bachelor of Science degreerequired; preferably in engineering, science or other related technical discipline. A minimum of 15 years pharmaceutical manufacturing experience may be substituted for the degree requirement.
- This is the first level for this role’s career ladder and as such recent graduates are accepted. One to three years experience in OSD pharmaceutical operations is preferred. Prefer experience in pharmaceutical production and process engineering.
- Understanding of cGMPs, demonstrated leadership, management and technical capabilities preferred.
- Excellent verbal, written, and interpersonal communication skills are essential as this is a client-facing role.
- Must have ability to plan, implement, and achieve significant, complex goals and objectives.
- Ability to lead by influence and drive results through others not under direct supervision.
- Ability to organize and implement projects that improve the operational effectiveness of product manufacturing.
- Experience with equipment IQ/OQ/PQ preferred.
- Experience in Lean Manufacturing/OpEx and Six Sigma is desired.
- Proficient in Microsoft Office Tools
- This is primarily a day shift position. Off-shift support is required as needed to ensure production, projects, and site goals and objectives are met.
- This position requires time in pharmaceutical production areas, sometimes for an entire shift depending on the business demands,that require appropriate uniform, gowning, and PPE.
- Sit and work with computer for up to 8 hours in a day.
- Frequent sitting, standing, walking, and reading of written documents.
- Talking, writing, and listening.
- Occasional lifting and/or moving up to 25 pounds.
- Minimal travelrequired