Supervisor, Manufacturing Sciences & Technology
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About the role
Strategic client facing leader of the MS&T team on the behalf of the organization. Works cross functionally with project managers, manufacturing, label design and control, quality assurance, quality control, supply chain, and facilities departments to effectively transfer and maintain processes in the facility. Participates and leads commercial manufacturing transition and support for process development. Enhance productivity by exploring, analyzing, facilitating, and leveraging efficiency initiatives for packaging processes through The Catalent Way. Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements. Bridge the focus areas of Project Management, Operations, Quality, EHS, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless packaging. Leads the compilation of process data, including communicating project status, and delivering internal and client presentations. Collects and trend process data for external (Clients) and internal review to ensure process consistency. Provides business case for process improvement projects. Other duties assigned The Candidate Bachelor's degree in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, OR a HS Diploma/GED and 4+ years of relevant experience required. Experience with Upstream and Downstream processes of cGMP clinical packaging. Project management experience/skills required including method transfers, and risk assessment. Knowledge of regulatory, validation and documentation requirements for product development, commercial production, and site transfers. Experience in investigating and closing out deviations, OOS, CAPAs, and change controls. Experience working on late phase and commercial programs is a plus. Knowledge of thermoforming/cold-forming equipment is required. A good working knowledge of Microsoft Office (Word, PowerPoint, Excel and Visio) and TOPS Pro (Total Optimization Packaging System) or similar software program Ability to learn and use software packages (e.g. TrackWise®, ComplianceWire®). Demonstrated strong working knowledge of Tech Transfer (Internal and External). Understanding and application of Risk Assessment tools (Hazard Analysis, FMEA, etc.). Why you should join Catalent Career growth with a clear path and regular performance reviews Day-one benefits: medical, dental, vision 401(k) match , tuition reimbursement, and wellness perks Paid time off: 152 hours + 8 holidays Inclusive culture with Employee Resource Groups and community initiatives Discounts from 900+ merchants via Perkspot A mission-driven workplace where your work helps save lives 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. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. 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