Assistant Scientist / Associate Scientist / Operations Scientist R&D - United States
- Maintain and improve laboratory and business systems that support development and commercialization of new and reformulated products.
- Create tools to make current results visible in assigned R&D systems. Create and deliver effective training resources and presentations for assigned R&D systems.
- Assist lab customers in understanding and following processes and procedures for assigned systems.
- Coaching/Mentoring: promote a culture of GxP compliance and personal integrity.
- Provide prompt service and effective communication in response to laboratory customers’ requests and questions. Comply with applicable cGMPs, cGLPs, any specific regulatory guideline, and company SOPs on a consistent basis. Meet required quality and service standards in the maintenance of all assigned operational systems, software applications or business processes.
- Create/revise procedures (SOPs, SWIs) to govern laboratory and business processes.
- Follow and improve standard work to visually signal workflow, barriers and/or risks. Participate in process improvement projects that gain efficiency and/or quality in R&D systems.
- Track and trend department service results, quality events, software errors and/or deviations.
- Prepare and defend technical documentation that supports change control, deviations/investigations or risk assessments.
- Collaborate with corporate partners (e.g., IT&S and Quality) to develop/innovate systematic or programmatic solutions to business problems.
- Lead routine laboratory or system audits and communicate findings to management.
- Detailed knowledge and experience in the practices of laboratory sciences.
- Advanced knowledge of cGXP principles and experience in monitoring and/or ensuring GxP compliance.
- Expertise in the use and/or administration of GxP software applications.
- Basic knowledge of continuous improvement and experience with application of lean principles for business system problem solving.
- Pharmaceutical Sciences, Engineering or closely allied life sciences discipline: BS + 0 years for Assistant.
- BS + 2 years or MS or PhD + 0 years for Associate. BS + 5 years or MS + 2 years or PhD + 0 years for Scientist.