SME – BioPharma Process – BLS Raleigh, NC or Remote
Exyte
This is a Full-time position in Las Vegas, NV posted February 13, 2022.
Summary
The 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
