Manufacturing Product Lead

Catalent Pharma Solutions • Kansas City, MO

21h • Onsite

About The Position

We have an opportunity for a Manufacturing Product Lead to join our team. In this role, you will provide technical support for oral solid dose process manufacturing, including process improvements, technology transfer, investigations, and troubleshooting. You will act as a subject matter expert for multiple processing operations and provide technical leadership for commercial product processes. This position offers the chance to work closely with cross-functional teams and clients to ensure quality, compliance, and continuous improvement in a dynamic environment.

Requirements

• Bachelor of Science degree required, preferably in engineering, science, or a related technical discipline. A minimum of 15 years of pharmaceutical manufacturing experience may substitute for the degree requirement.
• Excellent verbal, written, and interpersonal communication skills, as this is a client-facing role.
• Proficiency in Microsoft Office tools.

Nice To Haves

• Understanding of cGMPs with demonstrated leadership, management, and technical capabilities.
• Experience with equipment IQ/OQ/PQ.
• Experience in Lean Manufacturing, Operational Excellence, and Six Sigma.
• One to three years of experience in oral solid dose pharmaceutical operations, preferably in pharmaceutical production and process engineering.

Responsibilities

• Collaborate with Manufacturing, Engineering, Maintenance, EHS, and Quality to optimize productivity, safety, product quality, and supply reliability in compliance with cGMPs.
• Ensure commercial drug product manufacturing is Ready to Execute by authoring, reviewing, and approving master batch records, bills of materials, equipment recipes, and cleaning verification forms.
• Initiate process manufacturing area change proposals for assigned projects or in support of Manufacturing.
• Partner with commercial clients on technical issues and act as product technical steward during client interactions.
• Provide technical support for process manufacturing areas, including investigation and correction of product or process-related problems, troubleshooting, and improvements.
• Serve as a subject matter expert during internal audits and regulatory inspections for technical aspects of the drug product process.
• Identify, execute, and implement continuous improvement projects to reduce cost, improve quality, enhance safety, and simplify processes for better compliance.
• Support Manufacturing aspects of annual product reviews, continued process verification, risk assessments, and FMEAs, with at least 25% presence on the shop floor.
• Lead technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites into Kansas City or to other Catalent sites, as well as between clinical and commercial manufacturing.
• Perform all other duties as assigned.

Benefits

• Defined career path with annual performance reviews and feedback.
• Diverse and inclusive culture.
• Opportunities for career growth within an organization dedicated to improving lives.
• 152 hours of paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective on day one of employment.
• Tuition reimbursement program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior