Senior Specialist, Quality Control Analytical Testing
Bristol Myers Squibb
3 months ago
On-site
Summit, NJ
Operations
Purpose & Scope
- QC Senior Scientist supports analytical testing at QC Analytical Testing (CAR T manufacturing) during clinical/commercial phases. Performs/oversees flow-cytometry and molecular-based testing for stability, validation, critical reagent qualification, training, and critical support.
- Schedule: Wed–Sat day shift.
Required Competencies / Skills
- Advanced hands-on analytical experience (flow-cytometry, molecular techniques) and knowledge of pharmaceutical product characterization/transfer.
- Ability to accurately apply Global Regulatory and cGMP requirements.
- Strong technical writing, problem-solving, and logical thinking.
- Represent the group on cross-functional teams.
- Independently execute in a high-paced environment; meet deadlines; prioritize multiple projects.
- Communicate effectively with peers and management (local/global).
Education & Experience
- Bachelor’s degree or equivalent (preferably science) required.
- Advanced degree preferred.
- 2–4 years relevant analytical testing/QC experience (preferably regulated environment).
- Preferred: sterile cell culture, polychromatic flow-cytometry panels, flow-cytometry data analysis, ELISA, qPCR.
Duties & Responsibilities
- Perform QC analytical testing (cell-based in-vitro flow, ELISA, qPCR for critical reagent concentration) and troubleshoot complex issues.
- Develop/write/execute methods, protocols, reports, and related documents; prepare continuous improvement projects.
- Peer review testing data; ensure compliance with procedures and cGMP; complete reviews per release timelines.
- Support document revisions, CAPA, and investigation/deviation tasks.
Benefits (explicitly stated)
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs (incl. EAP), 401(k), disability and life insurance, and related financial protections.
- Paid time off options and additional eligibility-based time off (per plan terms).
- QC Senior Scientist supports analytical testing at QC Analytical Testing (CAR T manufacturing) during clinical/commercial phases. Performs/oversees flow-cytometry and molecular-based testing for stability, validation, critical reagent qualification, training, and critical support.
- Schedule: Wed–Sat day shift.
Required Competencies / Skills
- Advanced hands-on analytical experience (flow-cytometry, molecular techniques) and knowledge of pharmaceutical product characterization/transfer.
- Ability to accurately apply Global Regulatory and cGMP requirements.
- Strong technical writing, problem-solving, and logical thinking.
- Represent the group on cross-functional teams.
- Independently execute in a high-paced environment; meet deadlines; prioritize multiple projects.
- Communicate effectively with peers and management (local/global).
Education & Experience
- Bachelor’s degree or equivalent (preferably science) required.
- Advanced degree preferred.
- 2–4 years relevant analytical testing/QC experience (preferably regulated environment).
- Preferred: sterile cell culture, polychromatic flow-cytometry panels, flow-cytometry data analysis, ELISA, qPCR.
Duties & Responsibilities
- Perform QC analytical testing (cell-based in-vitro flow, ELISA, qPCR for critical reagent concentration) and troubleshoot complex issues.
- Develop/write/execute methods, protocols, reports, and related documents; prepare continuous improvement projects.
- Peer review testing data; ensure compliance with procedures and cGMP; complete reviews per release timelines.
- Support document revisions, CAPA, and investigation/deviation tasks.
Benefits (explicitly stated)
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs (incl. EAP), 401(k), disability and life insurance, and related financial protections.
- Paid time off options and additional eligibility-based time off (per plan terms).