Senior Manufacturing Product Lead

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

The Candidate

• Bachelor of Science degree required; preferably in engineering, science or other related technical discipline. 

• 7+ years experience in OSD pharmaceutical operations is required. Prefer experience in pharmaceutical production and process engineering. 

• 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

• Experience in Lean Manufacturing/OpEx and Six Sigma is desired.

Why you should join Catalent

• Career growth with a clear path and regular performance reviews

• Day-one benefits: medical, dental, vision

• 401(k) match, tuition reimbursement, and wellness perks

• Paid time off: 152 hours + 8 holidays

• Inclusive culture with Employee Resource Groups and community initiatives

• Discounts from 900+ merchants via Perkspot

• A mission-driven workplace where your work helps save lives

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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