Scientist, Analytical Development

Overview

Brain Child Bio  is seeking to hire an experienced Scientist in Analytical Development to add to our team supporting clinical development of CART therapies to treat pediatric brain malignancies. The Scientist will be responsible for the design, development, qualification and transfer of flow cytometry methods to support cellular drug product and vector drug substance GMP-release and characterization. The ideal candidate would have deep flow/spectral cytometry knowledge and experience implementing flow assays to support GMP manufacturing.

The candidate would also be familiar with ICH guidance and phase-appropriate method development, qualification and life cycle management in support of cell and gene therapy manufacturing. The candidate would also be a proficient problem solver and be able to work effectively in matrixed environments including internally across Research and Process Development teams, and externally with contract manufacturing organizations.

• Work collaboratively with internal Brain Child Bio  Research, Process Development and Analytical Development teams and with external partners at contract manufacturing organizations.
• Design, develop and qualify flow cytometry and spectral cytometry methods for release and characterization of pre-clinical through late-stage CAR T programs.
• Independently lead analytical method transfers and support existing method life cycle management at contract manufacturing organizations.
• Author ELNs, SOPs, protocols and reports.
• Review and approve contract manufacturing organization methods, protocols and reports.
• Manage direct reports.

• 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.
• Experience with a broad range of cytometry platforms (BD, Beckman, Cytek, Sony, etc.) is highly desired.
• 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.
• Previous experience with analytical method qualification, transfer and life cycle management desired.
• Proficiency with life science data analysis tools (Flow Jo, Prism, JMP, Excel, etc.).

$135,000 - $155,000 a year