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Catalent Pharma Solutions Group Leader, Biologics Validation in Kansas City, Missouri

Job Description

Position Overview:

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 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.

Position Summary

The Group Leader, Biologics Validation is primarily responsible for managing and coordinating all required Validation activities and associated documentation including equipment qualification, Computer Systems Validation (CSV), and Continued Process Verification. The Group Leader is also responsible for reading, interpreting, and applying current industry standard validation practices., as well as interacting with clients and aiding in external regulatory and client audits of the KCM Bio facility.

The Role

  • Manages and coordinates all Validation activities associated with new/existing equipment qualification, system/instrument periodic review and data integrity, and CSV.

  • Manages team of associates performing network and system IT work for Biologics department.

  • Serves as department subject matter expert for all validation related items during internal client, external client, corporate, and regulatory agency audits.

  • Reviews department Validation documents and procedures. Maintains them in a current state with all corporate, cGMP, ISPE, GAMP, ICH, Current Industry Standards, The Code of Federal Regulations and FDA initiatives.

  • Acts as the project Validation Lead for all department facility expansions. Includes developing Scope, Schedule and Budget for associated validation activities. Maintains relationships with consultants/vendors and internal clients for the coordination of activities and qualification of all items.

  • Generates protocols and reports for CSV as well as equipment and facility qualification as required. Ensure documents are in accordance with the current department, site, and corporate Validation SOPs and guidelines.

  • Oversees/executes approved protocols and coordinates execution of activities with other departments (e.g., engineering, maintenance, production, etc.), as required.

  • Recruits, trains and develops department members.

  • Builds and sustains employee engagement by creating a culture of efficient execution and an environment which individuals and teams can excel.

  • Adheres to and supports EH&S expectations

The Candidate

Education or Equivalent:

Bachelor’s, Master’s, or Ph.D. Degree in Computer Science/Engineering; with experience in life sciences preferred.


Within the pharmaceutical or medical device industry with emphasis preferred in the Validation or Quality areas:

  • Bachelors: 7-10 years of experience

  • Masters: 6-8 years of experience

  • PhD: 4-6 years of experience

Knowledge/Skills Requirements:

  • Knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively is preferred.

  • Demonstrated capacity for sound decision making and professional judgment.

  • Excellent computer skills.

  • Able to manage people, priorities and projects prioritizing effectively. Must communicate clearly.

  • Capability to work in a matrix organization.

Catalent’s standard leadership competencies

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • 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) .