SME - Bioprocess - BLS - Raleigh, NC or Remote

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

Job Description:

SummaryThe SME - Bioprocess is the Subject Matter Expert responsible for having and providing knowledge in all phases of biomanufacturing design and operations. The focus areas would include both fed-batch and continuous manufacturing platforms, new modalities such as ATMPs and ADCs, and the skills to identify/address risk and operational efficiency. 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 biologic 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 bio-manufacturing operations*10+ year of consulting experience in bio-manufacturing preferred

Keywords: Exyte, Orlando , SME - Bioprocess - BLS - Raleigh, NC or Remote, Other , Orlando, Florida