Quality Control Specialist CAR-T
Quality Control Specialist CAR-T
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Job Description
Role Responsibilities:
As a QC/Analytical Scientist/Sr Scientist a typical day might include the following:
- Collaborate with partner groups in research and development and manufacturing to bring inhouse develop and validate QC/analytical methods to evaluate novel CGT candidates using QC/analytical methods such as digital PCR qPCR ELISA Flow Cytometry electrophoresis Spectrophotometry cell staining cell viability cell morphology and cellbased methods (e.g. potency biological titer) for tech transfer to GMP testing groups.
- Proactively engage and lead troubleshooting activities for established methods by providing scientific support across the manufacturing life cycle.
- Independently create scientifically sound project QC/Analytical plans and relevant experiments using highlevel project timelines and goals.
- Perform the scientific interpretation and reporting of the results. Present results to management and at crossgroup meetings.
- Use statistical tools to develop quantitative measures in decisionmaking around assay validation and performance.
- Drive the writing review and approval process of procedures protocols reports and GMP documents.
- Stay at the leading edge of industry trends and agency requirements in the CGT analytical space as it pertains to development and transfer in the GMP environment.
- Order reagents and lab materials.
- Create and maintain high quality records of all experimental work carried out.
- Drive experimental troubleshooting investigation via QMS system/SOPs (e.g. OOS/OOT/Deviations/RCA/CAPA)
- Train juniorlevel group members and act as a mentor within the laboratory.
Additional information
Experience and skills required
QC/Analytical Scientist: 36 years of Cell therapy/Biologics experience.
Senior QC/Analytical Scientist: 612 years of Cell therapy/Biologics experience.
- You can comfortably work in a dynamic fastpaced closely collaborative environment on multiple projects in parallel independently or as a group.
- Experience with a wide range of QC analytical techniques particularly cellbased analytical methods (Incucyte/xCELLigence) qPCR ELISA and flow cytometry.
- Excellent demonstrated understanding of quality and regulatory guidance and documentation governing cellbased and biologics development.
- Experience in the Quality Control (DS/DP testing and release) of cell and gene therapy products and analytics in PD or GMP environments.
- Qualityminded attention to detail problem solving and proactive attitude.
- Detailoriented curious to learn and implement new ideas and techniques and lead multiple projects in a teambased environment.
- Able to work under rapidly shifting priorities and timelines.
- Highly motivated rigorous flexible innovative and good teamworking skills
- Excellent organizational communication and time management skills
- Youre interested in developing into a mentor and leader within the group.
Prior experience in analytical method development molecular biology Cell therapy and Vector analytics is highly preferred. Level is determined based on qualifications relevant to the role.
Qualifications :
PhD/MSc/BSc in biotechnology biology immunology Cell Biology or a relevant lifescience discipline with relevant industry experience within QC and analytical method development function.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
