Catalent Pharma Solutions Manufacturing Product Lead in Kansas City, Missouri
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
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 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. The Manufacturing Product Lead 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.
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.
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.
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.
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.
Education or Equivalent:
- Bachelor of Science degree required; preferably in engineering, science or other related technical discipline. Relevant work experience at Catalent may be considered in lieu of a Bachelor’s degree.
- 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.
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 desired. Experience in Lean Manufacturing/OpEx and Six Sigma is desired.
Catalent’s standard leadership competencies
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually
Potential for career growth within an expanding team
Defined career path and annual performance review and feedback process
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 www.catalent.com/careers to explore career opportunities.
C atalent 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, protected veteran status, sexual orientation or gender identity. 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 DisabilityAccommodations@catalent.com . 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.
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!
personal initiative. dynamic pace. meaningful work.
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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .