Scientist

Job Title: Scientist/Engineer
Contract Duration: 6 Months
Location: Summit, NJ
Work Type: 100% onsite, first shift - Monday to Friday 9 am to 5 pm

Job Description:

• 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.

Job Duties and 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.
• The Scientist/Engineers 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 in 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, and apply Global Regulatory and cGMP requirements.
• Ability to support health authority inspections.
• Knowledge of data trending and tracking, including the 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

Required 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.

Benefits:

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Job Type: Full-time

Pay: $54.89 - $58.42 per hour

Schedule:

• 8 hour shift

Work Location: In person

Salary : $55 - $58