Key skills
Statistical AnalysisReact
About this role
100% onsite
Work Schedule: first shift (9am to 5pm) Monday to Friday
Duration: 6 months(possibility of extension for right candidate depending on performance)
Minimum Associate degree required or prefer Bachelor's degree
Must Haves:
Minimum Associate degree required or preferred a Bachelor s Degree in science or engineering, preferably
in Biochemistry, life sciences or related engineering discipline.
Technical writing skills and ability to collaborate effectively in cross functional teams.
Work Schedule: first shift (9am to 5pm) Monday to Friday
Duration: 6 months(possibility of extension for right candidate depending on performance)
Minimum Associate degree required or prefer Bachelor's degree
Must Haves:
Minimum Associate degree required or preferred a Bachelor s Degree in science or engineering, preferably
in Biochemistry, life sciences or related engineering discipline.
Technical writing skills and ability to collaborate effectively in cross functional teams.
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Job Description:100% onsite
Work Schedule: Mon-Fri(normal business hours)
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:
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) or Infinity.
Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality
Control.
Education and Experience
Minimum Associate degree required or preferred a Bachelor s Degree in science or engineering, preferably
in Biochemistry, life sciences or related engineering discipline.
Minimum 1 year 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.