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Manager Of Stability And Sample Management

Expired Job

Catalent Kansas City , MO 64126

Posted 4 months ago

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.


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Manager Of Stability And Sample Management

Expired Job

Catalent