Staff Process Specialist - Manufacturing

Role Responsibilities Provide technical input to resolve process problems on and off the production suites. Coach manufacturing personnel on critical process steps. Support implementation of process/work improvements in the suites. Support CAPA implementation for process-related improvements. Support onsite educational programs to enhance manufacturing technical competence. Support manufacturing activities according to approved protocols, regulations, and schedules. Support technology transfer and liaison with process science/technology transfer teams for transfer and startup. Prepare and present reports by collecting, analyzing, and summarizing information and trends. Lead investigations into process variances per site procedures. Ensure policies/procedures are administered and comply with regulatory requirements. Communicate with supervisors on major process, schedule, and material issues. Guide and oversee validation activities for manufacturing equipment and processes. Interface with Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance, and Quality Control. Support safety standards and technical/engineering safety improvements. Track and trend technical and business process metrics. Perform cGMP audits of the production area. Represent manufacturing during regulatory and client audits and respond to some findings. Write/review/approve SOPs, specifications, regulatory filings, and other controlled documents as needed. Lead and implement continuous improvement initiatives. Act as system owner for defined manufacturing equipment and schedule non-routine activities. Qualifications & Required/Preferred Skills BS in Life Sciences or related field. cGMP manufacturing environment knowledge; familiarity with formulation, aseptic filling, visual inspection (manual/automated), assembly, labeling, and/or packaging of liquid and lyophilized injectable products. Strong interpersonal, communication, negotiation, and problem-solving skills. Ability to work toward established goals individually or as part of a team. Ability to understand and support stakeholder/team needs. Preferred: technology transfer and equipment/process validation experience (aseptic, parenteral fill/finish); previous technical support experience. Plus: lyophilization experience; experience operating/qualifying high-automation equipment. Experience Level (based on title) Principal Process Specialist: 8 years relevant cGMP manufacturing/engineering/scientific. Staff Process Specialist: 10 years relevant cGMP manufacturing/engineering/scientific. Senior Staff Process Specialist: 12 years relevant cGMP manufacturing/engineering/scientific. May consider equivalent experience in lieu of education. Application Instructions Apply now. #J-18808-Ljbffr Scorpion Therapeutics