Associate Scientist

100% onsite
Work Schedule: Wed-Sat- (7am-5pm) EST

PURPOSE AND SCOPE OF POSITION:

The Associate Scientist/Engineer is responsible for leading 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.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

1. Working experience of deviation investigations utilizing root cause analysis tools.
2. Working experience in the CAPA process and ability to identify and verify effectiveness.
3. Technical writing skills and ability to collaborate effectively in cross functional teams.
4. Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.
5. Ability to support health authority inspections.
6. Knowledge of data trending and tracking, including use of statistical analysis software a plus.
7. Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.
8. Ability to set priorities, manage timelines and effectively react/manage changing priorities.
9. Ability to work with management (global and site) and support corporate and departmental goals.
10. Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.
11. Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system) or Infinity.
12. Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.

Education and Experience:

1. Requires a Bachelor's Degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).
2. Minimum 1 year of relevant work experience, preferably in a health authority regulated environment.
3. Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).

DUTIES AND RESPONSIBILITIES:

1. Conduct thorough investigations (Environmental Monitoring, deviations, etc.) utilizing root cause analysis tools.
2. Lead investigations and cross functional investigation teams, and close reports in a timely manner.
3. Perform GEMBA walks with stakeholders to better understand process steps and evaluate Root Cause Analysis.
4. Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness.
5. Assess potential impact and risk to product or process associated changes may have upon change implementation and develop an appropriate mitigation strategy.
6. May Initiate change control documentation.
7. Identify functional area SMEs to perform impact assessments as part of the change management process.
8. Ensure all investigations are completed in a timely manner. Notify stakeholders of any delays in a timely manner.
9. Provide technical support for manufacturing investigations / CAPAs / change controls as needed.
10. Support deviation investigation defense during audits and site inspections related inquiries.
11. Handle complex issues and solve problems with minimal guidance.
12. Serve as author or technical reviewer of departmental procedures as appropriate.
13. Employ lean manufacturing / six sigma principles to continuously improve products, processes and systems.
14. Continuously support S12, living the "patients first” mission and fostering a "Right First Time” mindset.

WORKING CONDITIONS (US Only):

1. The incumbent will be working 80% to 90% of the time in an office environment.
2. The incumbent will be working 10% to 20% of the time in a manufacturing and/or laboratory setting.
3. The incumbent may travel between NJ sites for training, meetings or corporate events on occasion.
4. The incumbent will need to have flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.