Manufacturing Product Lead

Manufacturing Product Lead

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a 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. This individual serves as a Subject Matter Expert (SME) for multiple processing operations and provides technical leadership for commercial product processes.

This is a full-time salaried position: Monday – Friday, on 1st shift 7am-4pm.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

• Partner with commercial clients as required on technical issues affecting their drug product(s). Act as product technical steward on client interactions. Collaborates cross-functionally with Manufacturing, Engineering, Maintenance, EHS (Environmental Health & Safety) 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
• Initiates process manufacturing area change proposals as required for assigned projects or in support of Manufacturing. Serves as a subject matter expert during internal audits and regulatory inspections for technical aspects of the drug product process
• Provides technical support for process manufacturing areas, including investigation and correction of product/process-related problems and deviations, process troubleshooting and improvements
• 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
• 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
• All other duties as assigned

The Candidate:

• Bachelor of Science degree required; preferably in engineering, science or other related technical discipline. A minimum of 15 years of pharmaceutical manufacturing experience may be substituted for the degree requirement
• Minimum requirement of one year of experience with Oral Solid Dosage (OSD) manufacturing or pharmaceutical operations. Experience in pharmaceutical production and process engineering preferred
• Must have familiarity with Microsoft Office (Word, Excel, Outlook, Teams, etc.), and experience with Minitab and/or SharePoint is preferred
• Must have client facing customer service experience
• Understanding of cGMPs, demonstrated leadership, management and technical capabilities preferred
• Experience with equipment IQ/OQ/PQ preferred
• Experience in Lean Manufacturing/OpEx and Six Sigma is desired
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 25 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401K match
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or start a new degree
• WellHub program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 . 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ) .