Scientist – Analytical Development

WHAT YOU’LL DO

• Independently design, test, and implement quality-based analytical assays to support the characterization and release of cell therapy products.
• Actively contribute to the development, and efficient execution of analytical methods for characterization of cell therapy process development, process manufacturing and drug products.
• Serve as an analytical SME to develop and perform in vitro cell-based analytical assays (cytotoxicity, cytokine, proliferation, etc.) for cell therapy product development
• Provide analytical support for clinical-scale IND-enabling manufacturing operations including:
- Preparation of test methods, SOPs and technical development reports
- Assay qualification, provide technical support and tech transfer to Quality Control in supporting of QC assay establishment and GMP lot release
• Provide technical expertise and leadership within Analytical Development teams and in a matrix environment
• Establish data tracking and trending analyses of process developmental runs and cGMP production runs, including evaluation of critical reagents and lot to lot variability, in order to improve process and assay standardization
• Good understanding of cGMP environment, and Quality by Design (QBD) principles for assay development, qualification and validation preferred
• Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges
• Organize, communicate, and present complex data sets to key stakeholders and senior management
• Provide leadership and mentorship to junior SRAs

WHO YOU ARE

• Master’s degree with 5+ years of experience, or a Bachelor’s degree with 7+ years of experience, in Biotechnology, Bioprocess Engineering, Immunology, Molecular Biology, Biochemistry, or a related field, along with relevant industry experience
• Excellent mammalian cell culture skills 
• Experience with immunological assays, such as cytokine/chemokine analysis (ELISA, Luminex or intracellular cytokine staining) and cytotoxicity
• Proficiency using data analysis and interpretation using software such as GraphPad, Excel and JMP
• Experience in technical development of analytical methods to support cell and gene therapy biologics and other advanced modalities in pre-clinical development and clinical stage settings (Phase II experience a plus)
• Ability to learn new skills quickly to advance method development in support of drug product manufacturing
• Strong problem-solving skills, with the ability to anticipate issues and identify solutions
• Demonstrated ability to work as a team player in a collaborative environment and coordinate tasks across multiple projects to meet deadlines
• Ability to lead the development of cell based assays successfully and handle multiple challenges under expedited timelines
• Excellent communications, technical writing, presentation, written and verbal skills
• Excellent organizational skills: Proactive management of multiple tasks of varying complexity simultaneously
• Leadership to raise the level of the team's technical capabilities
• Willingness to accept responsibilities outside of initial job description