Catalent Pharma Solutions Manager of Stability and Sample Management in Kansas City, Missouri

Job Description

Manager of Stability and Sample Management

Position Summary:

Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8

The Manager of Stability and Sample Management will supervise and coordinate the activities of teams of Supervisors and Associates along with being responsible for a team of up to 12 staff. This position will report directly to the Director, Site Operations Support.

The activities of the Manager of Stability and Sample Management will include the management of approximately 25,000 samples received at site for testing and the management of site Stability Chambers and the studies and samples within the chambers. Managing of samples and chambers in accordance with the requirements of regulatory requirements, project contracts and/or technical agreements assigned to the Site Operations Support Department, participating in and completing HR activities (performance reviews, time entry approval, PTO approval, salary adjustments, etc.), supporting client audits/visits, and communicating with cross-functional teams on analytical activities.

The Role/Job Duties:

  • Plan, prioritize, organize and execute the conduct of the Sample Management Office and Stability Chambers work within the Site Operations Support Department in accordance with the requirements of the client contract and/or technical agreement.

  • Oversee projects and maintain project timelines and budget, serve as Project Technical Lead with internal and external customers and serve as Subject Matter Expert for stability and stability environmental conditions (chambers) and Sample Management activities.

  • Ensure that safe working practices are adopted in the areas and to comply with in-house SOPs and other safety legislation - Perform checking & verifying of documentation in accordance with in-house SOPs.

  • Assist in production of costing and timelines for client projects - Report revenue forecasts on a regular basis.

  • Maintain awareness of modern techniques and their application to Pharmaceutical Sciences activities.

  • Ensure that appraisals and performance reviews are carried out in accordance with company policy. Identify training needs of subordinates through discussion and with reference to the core competencies.

  • Assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client SOPs and methodologies and following the requirements of GMP.

The Candidate

Education or Equivalent:

  • Bachelors Degree in a scientific field preferred.

  • 5 years relevant industry experience with 3 years of people leading experience preferred.

Essential Requirements/Knowledge:

  • Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.

  • Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings.

  • Leadership development skills are expected - Excellent motivator, well versed in team development.

  • Understand the details of regulatory CMC filing package and analytical and formulation documentation required. Has the ability to write and review documents for regulatory filings.

We will identify candidates based on the following:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits:

  • Join a high growth and fast paced organization with a people focused culture

  • Global exposure, defined career path and annual performance review and feedback process

  • Competitive PTO, Medical, Dental and Vision Benefits and 401K

About Catalent

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. 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, 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 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 offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

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.