Catalent Pharma Solutions Manufacturing Product Lead in Kansas City, Missouri

Job Description

Position Title Manufacturing Product Lead

Position Summary

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.

The Role

  • 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.

The Candidate

  • Bachelor of Science degree required; 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

Physical Requirements:

  • 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 travel required

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

Grow with us. Be challenged. Make a personal impact.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.