Job Description:The Senior Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. The Sr. role will be assigned more complex deviation investigations, and often need to create and facilitate teams to execute all elements in a timely matter. Deviation investigation includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems.(ads1)Job Responsibilities:Serve as author or technical reviewer of departmental procedures as appropriate.Perform GEMBA walks with stakeholders to better understand process steps, and evaluate Root Cause analysis.Provide mentorship, guidance and training to junior members.Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.Provide technical support for manufacturing investigations / CAPAs / change controls as needed.Lead medium and high -risk investigation teams with the ability to summarize progress to Sr.Management, collect information from the triage team, and gather necessary supporting data from technical and quality teams outside of S12Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.May Initiate change control documentationLead deviation investigation defense during audits and site inspections for QC compliance related inquiries.Identify functional area SMEs to perform impact assessments as part of the change management process.Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.Handle complex issues and solve problems with minimal guidance. Manage teams to support more complex investigationsJob Requirements:Knowledge of data trending and tracking, including use of statistical analysis software a plus.Proven ability to accurately and completely understand, follow, interpret, and apply GlobalRegulatory and cGMP requirements.Ability to work with management (global and site) and support corporate and departmental goals.Advanced technical writing skills, and capability to review, improve, and approve investigation reports from more junior team membersHands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control.Proven delivery of complex investigation reports is required for the Sr. Level role.Working experience in the CAPA process and ability to identify and verify effectiveness.Ability to set priorities, manage timelines and effectively react/manage changing priorities.Advanced working experience of deviation investigations utilizing root cause analysis tools.Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.Ability to train and mentor junior associates to foster and develop their expertise.Capability to kickoff and lead limited duration investigation teams, to ensure timely completion of more complex investigations requiring scientific work outside of S12 site experience supporting health authority inspections. Sr. scientists/engineers will often defend more complex investigation reports in Regulatory Investigator questioning during Health Authority audits.Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).Job Details:Company:ASK ConsultingVacancy Type:Full TimeJob Location:Jeffreys BayApplication Deadline: N/A(ads2)Apply Hereinstantcareers.net#J-18808-Ljbffr
