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Associate Manufacturing Technology Specialist

Company: Catalent Pharma Solutions, Inc.
Location: Bloomington
Posted on: November 18, 2021

Job Description:

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 The Associate 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. Catalent Pharma Solutions in Bloomington, Indiana is a state of the art, GMP manufacturing facility, providing one million sq/ft of a drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives. This position works days; Monday - Friday 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 and 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 and develop in-process test strategy for manufacturing process at large scale * Write or direct the writing of GMP manufacturing documentation, including Process Batch Records, Buffer and Media Formulation records, Sample Plans, Bills of Materials * Provide technical training as necessary to operators * Monitor process data, identify trends, present data, and propose action as necessary and perform technical troubleshooting and investigations of process issues * Write or direct the writing of post run reports (e.g., Manufacturing Campaign Report) * Provide technical guidance and oversight to the validation group to support Process Validation and Continued Process Verification * Work with Process Development and Process Engineering to assess and implement new technology in large scale manufacturing * Mentor junior level Scientists and Engineers, co-ops and interns * Maintain relationships with process technology vendors to understand new technology development The Candidate * Bachelor's degree in Science * Master's degree preferred * 0+ years of experience * GMP experience preferred * Must be able to read and understand English-written job instructions and safety requirements Catalent'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 Develops Catalent'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 or lyophilized vials and prefilled syringes, along with an array of support services. The Bloomington site is proud to offer the following: * Defined career path and annual performance review and feedback process * 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 Program 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. 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 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. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Keywords: Catalent Pharma Solutions, Inc., Bloomington , Associate Manufacturing Technology Specialist, IT / Software / Systems , Bloomington, Indiana

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