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.
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.