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SME - BioPharma Process - BLS Raleigh, NC or Remote

Company: Exyte
Location: Cleveland
Posted on: January 16, 2022

Job Description:

SummaryThe SME - BioPharma Process is responsible for having and providing knowledge in dosage forms including pills/aerosols, creams, and would also include continuous manufacturing platforms. Must also be experienced in risk identification/mitigation for pharmaceutical operations. Must be proficient in communications of operational analysis and design basis in order to align Customer needs and expectations with deliverables.
Duties*Ensures customers are provided with the right technical solution within process discipline*Inspires customers by providing innovative solutions/options for project feasibility and conceptual design*Develops technical solutions around operational and business goals*Conducts reviews of risks and facilitates implementation of design approaches to mitigate those risks*Uses specialist Subject Matter Expert (SME) knowledge and experience to solve complex tasks around OSD/API drug substance manufacturing operations*Develops and implements tools for risk assessment and early-phase project execution framework*Delivers on-the-job knowledge sharing/training/mentoring within process discipline of LSC*Follows Industry technology trends and maintains knowledge within key technical disciplines*Conveys and shares knowledge within the Company*Reviews and assess lessons learned from projects, recommends improvements of tools/methods, and gives input to implementation*Reviews compliance aspects of process design against global regulatory standards, focused on CPPs*Supports development of new methods/tools for process design execution and improves existing solutions supporting an operational approach*Be engaged in local professional network*Participates actively in global site efforts as requested*Delivery of special courses/practical training in field of expertise*Other duties as assigned
---Requirements*Masters of Science degree or PhD in Process Engineering required *10+ years of experience in pharmaceutical operations*10+ year of consulting experience in pharmaceutical/API preferred

Keywords: Exyte, Cleveland , SME - BioPharma Process - BLS Raleigh, NC or Remote, Other , Cleveland, Ohio

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