Scientist, Analytical Development
About The Position
BrainChild Bio is seeking to hire an experienced Scientist in Analytical Development to add to our growing team supporting clinical development of CAR T therapies to treat pediatric brain malignancies. The Scientist will lead a team in support of routine analytical testing to enable process development and process characterization of cellular drug product manufacturing processes. The ideal candidate would have experience performing one or more types of analytical methods including cell-based assays, flow cytometry, cell counting platforms, qPCR, ddPCR and/or multiplex cytokine detection. The Scientist would also be familiar with ICH guidance and phase-appropriate method life cycle management, including method bridging strategies, in support of cell and gene therapy manufacturing. The candidate would also be a proficient problem solver and be able to work and communicate effectively in matrixed environments including internally across Analytical Development and Process Development teams.
Requirements
- Degree in biology, bioengineering, immunology, virology, microbiology or related discipline.
- Scientist qualifications include PhD with 0-2 years, MA/MS with 4-6 years, or BA/BS with 6-8 years of experience.
- Experience managing and collaborating with contract manufacturing organizations.
- Hands-on experience designing, developing, qualifying and transferring flow cytometry and spectral assays for QC release and/or characterization.
- A team player with a track record of successfully operating within cross-functional teams.
- Proficiency with life science data analysis tools (FlowJo, Prism, JMP, Excel, etc.).
Nice To Haves
- Experience with a broad range of cytometry platforms (BD, Beckman, Cytek, Sony, etc.) is highly desired.
- Previous experience with analytical method qualification, transfer and life cycle management desired.
- Hands-on experience with a broad range of analytical platforms (CytoFlex, MSD, QX200, Cellaca/NC-200) is highly desired.
- Experience managing direct reports.
Responsibilities
- Work collaboratively with BrainChild Bio Analytical Development and Process Development teams to coordinate method transfers, method optimizing/bridging, sample testing and data delivery.
- Oversee experiment performance by team members, perform experiments, analyze and review data from flow cytometry, cell counting platforms, qPCR, ddPCR and/or multiplex cytokine detection methods and deliver results to process development teams.
- Perform method optimization and method bridging studies to support high throughput process analytics.
- Co-lead new analytical method transfers from Analytical Development and support existing method life cycle management.
- Author ELNs, SOPs, protocols and reports.
- Train and manage direct reports.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
