BrainChild Bio is seeking to hire an experiencedย Scientistย inย Analytical Development to add to our growing teamย supportingย clinical development ofย CARย T therapiesย to treat pediatricย brain malignancies.ย The Scientistย willย lead a team inย support ofย routineย analyticalย testingย to enable process developmentย and process characterizationย ofย cellular drug productย manufacturingย processes.ย The ideal candidate would haveย experienceย performingย one or moreย types of analytical methodsย includingย cell-based assays,ย flow cytometry, cell counting platforms,ย qPCR,ย ddPCR and/orย multiplex cytokineย detection.ย Theย Scientistย wouldย alsoย be familiar with ICHย guidanceย andย phase-appropriate method life cycle management, including method bridging strategies,ย in support ofย cell and gene therapy manufacturing.ย The candidate would also be aย proficient problem solver and be able toย workย and communicateย effectivelyย in matrixed environments includingย internallyย acrossย Analytical Development andย Process Developmentย teams.ย ย ย
Responsibilities:
- Work collaboratively withย BrainChild Bioย Analytical Development andย Processย Developmentย teamsย to coordinate method transfers,ย method optimizing/bridging,ย sample testing and data delivery.ย
- Overseeย experimentย performanceย by teamย members, performย experiments, analyze and review data fromย flow cytometry, cell counting platforms, qPCR, ddPCR and/orย multiplex cytokine detection methodsย and deliver results to process development teams.ย
- Perform method optimization and method bridging studies to support highย throughput process analytics.ย
- Co-leadย newย analytical methodย transfersย from Analytical Developmentย and support existing method life cycle management.ย
- Authorย ELNs,ย SOPs,ย protocols andย reports.ย
- Train and manage direct reports.ย
Qualifications:
- Degree in biology, bioengineering, immunology, virology,ย microbiologyย or related discipline.ย ย
- Scientistย qualifications includeย PhDย withย 0-2ย years,ย MA/MSย withย 4-6ย years,ย orย BA/BSย withย 6-8ย yearsย ofย experience.ย
- Experienceย managingย andย collaboratingย with contractย manufacturingย organizations.ย
- Experience with a broad range of cytometry platforms (BD, Beckman,ย Cytek, Sony, etc.)ย is highly desired.ย
- Hands-onย experienceย designing,ย developing,ย qualifyingย and transferringย flow cytometryย and spectralย assaysย forย QC releaseย and/orย characterization.ย ย
- A teamย player withย a track recordย of successfullyย operatingย withinย cross-functional teams.ย
- Previousย experience withย analyticalย method qualification,ย transferย and life cycle managementย desired.ย
- Proficiencyย withย lifeย scienceย dataย analysis toolsย (FlowJo,ย Prism, JMP,ย Excel, etc.).ย
- Degree in biology, bioengineering, immunology, virology, microbiology or related discipline.ย ย
- Scientist qualifications include PhD with 0-2 years, MA/MS with 4-6 years, or BA/BS with 6-8 years of experience.ย
- Experience managing direct reports.ย
- Hands-on experience with a broad range of analytical platforms (CytoFlex, MSD, QX200, Cellaca/NC-200) is highly desired.ย
- A team player with a track record of successfully operating within cross-functional teams.ย
- Previous experience with analytical method qualification, transfer and life cycle management desired.ย
- Proficiency with life science data analysis tools (FlowJo, Prism, JMP, Excel, etc.).ย
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