Scientist/Engineer

Overview The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of S12 CAR T operations. This 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. The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams. Responsibilities Conduct thorough investigations (OOS, OOT, Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools. Lead investigations and cross functional investigation teams, and close reports in a timely manner Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis. Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness. Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy. May initiate change control documentation Identify functional area SMEs to perform impact assessments as part of the change management process. Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner. Provide technical support for manufacturing investigations / CAPAs / change controls as needed. Support deviation investigation defense during audits and site inspections for QC compliance related inquiries. Handle complex issues and solve problems with minimal guidance. Provide training to new investigations team members Serve as author or technical reviewer of departmental procedures as appropriate. Support manufacturing and Quality Control testing of CAR T products as needed. Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems. Continuously support S12, living the “patients first” mission and fostering a “Right First Time” mindset. Required Competencies: Knowledge, Skills, and Abilities Working experience of deviation investigations utilizing root cause analysis tools. Working experience in the CAPA process and ability to identify and verify effectiveness. Technical writing skills and ability to collaborate effectively in cross functional teams. Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements. Ability to support health authority inspections. Knowledge of data trending and tracking, including use of statistical analysis software a plus. Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking. Ability to set priorities, manage timelines and effectively react/manage changing priorities. Ability to work with management (global and site) and support corporate and departmental goals. 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). Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control. Ability to train new team members on the investigation process Education And Experience Requires a Bachelor’s Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred). Minimum 3 years of relevant work experience, preferably in a health authority regulated environment. Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus). An equivalent combination of education and experience may substitute. 100% onsite Work Schedule: (Mon-Fri) normal business hours This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myers-Squibb . The starting hourly compensation for this assignment is the following range ($51- $54.55/hr). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change. About ASK Consulting ASK Consulting is a staffing and recruitment solutions provider with extensive experience across IT, healthcare, engineering, finance, and more. Benefits ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law. Equal Opportunity Employer ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws. California Applicant Notice ASK Consulting is committed to complying with the California Privacy Rights Act (CPRA), effective January 1, 2023, as well as all relevant data privacy laws in the jurisdictions where we recruit and hire. To learn more, please review our Notice to California Job Applicants Regarding the Collection of Personal Information on our website. Applicants with disabilities may request this notice in an alternative format by contacting View email address on click.appcast.io. Fair Chance Employment Notice If you are selected for a position at ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local “Fair Chance” ordinances and laws, we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer. To learn more about how ASK Consulting collects and uses personal information during the recruiting process, please review our Privacy Notice and CCPA Addendum. As part of our recruitment efforts, we may ask you to disclose various categories of personal information, including identifiers, professional details, and educational background. ASK Consulting will use this information solely to facilitate the recruitment process. This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered “at will,” regardless of the expected assignment duration. #J-18808-Ljbffr Bristol Myers Squibb