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Senior Manufacturing Technology Specialist

Company: Catalent
Location: Bloomington
Posted on: February 11, 2019

Job Description:

Job DescriptionPosition Overview:-- 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. Title:-- Senior Manufacturing Technology SpecialistSummary The--Senior Manufacturing Technology Specialist's primary responsibility is to scale up and transfer processes--into full-scale manufacturing based on data provided by Process Development or by Client.----The Manufacturing Technology group provides a direct impact to patients by developing manufacturing processes to ensure quality and compliance expectations are met.-- The Role

  • Select appropriate equipment and single-use components to perform process at large scale, develop technical documentation (e.g., Process Flow Diagrams, Process Descriptions) to describe operation of the process at large scale
  • Meet with Process Development or client technical team to understand bench and pilot-scale data, develop in-process test strategy for manufacturing process at large scale
  • Write or direct the writing of GMP manufacturing documentation, including Process Batch Records, Sample Plans, Bills of Materials
  • Interact with client technical representatives, including Person in Plant observers on manufacturing floor, monitor process data, identify trends, present data, and propose action as necessary
  • Perform technical troubleshooting and investigations of process issues, perform and document formal deviation investigations as neededThe Candidate
    • Bachelor---s degree in Science
    • Master---s degree preferred
    • 5+ years of experience
    • GMP experience preferredCatalent---s standard leadership competencies that are used to interview and for Performance & Development:
      • Leads with Integrity and Respect
      • Delivers Results
      • Demonstrates Business Acumen
      • Fosters Collaboration and Teamwork
      • Champions Change
      • Engages and Inspires
      • Coaches and DevelopsCatalent---s facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services. The Bloomington site is proud to offer the following:
        • Diverse, inclusive culture
        • Competitive salary with quarterly bonus potential
        • Educational assistance/reimbursement
        • On-site fitness center and wellness programs
        • Excellent on-site cafeteria
        • Robust Employee Referral ProgramCatalent 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 to explore career opportunities.---- --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, and confirming your request for an accommodation and include the job number, title and location to 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.

          Keywords: Catalent, Bloomington , Senior Manufacturing Technology Specialist, IT / Software / Systems , Bloomington, Indiana

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