The Analytical Development Research Scientist I works with a high degree of independence and is adept at designing and executing complex experimental procedures within required timelines. Completes work in a resourceful, self-sufficient manner and is able to troubleshoot and design alternative approaches to achieve desired outcomes. Performs strategic planning consistent with regulatory guidance, implements innovative approaches and maintains a high level of technical knowledge. Authors and reviews method documents, analytical study protocols and reports. Works collaboratively within the analytical development team and cross-functionally with other groups to meet CMC organizational goals.
Responsibilities:
Develop, execute and optimize characterization and release assays either in manual or automated mode for identity, purity, strength and potency of biologics or gene and cell- based products
Evaluate and implement novel High Throughput (HTP) automated analytical platforms and robotic liquid handlers for sample preparation, sample run and automated data analysis for liquid chromatography, capillary electrophoresis, PCR, Flow cytometry, ELISA and cell- based functional/ potency assays
Provide routine analytical testing support to Cell and Gene Process Development activities including cell culture, purification, formulation and device.
Develop assay performance system, experience in writing analytical development protocols and reports, and develop analytical reagents inventory including reference standard materials as per regulatory standards
Develop assay design criteria using Design of Experiments (DOE) and other contemporary development tools
Perform either manual or automated test method qualification to establish specificity, sensitivity, linear range, precision and accuracy of test methods.
Transfer assays to QC and provide SME support for assay qualification
Maintain excellent written documentation (e.g. lab notebook and test forms).
Requirements:
Ph.D in Analytical Chemistry, Biochemistry, Cell & Molecular Biology, Chemical Engineering or related discipline
0-3 years of industry experience in HTP and automation analytical assay development
Demonstrated developing analytical methods in compliance with ICH guidelines
Hands-on experience with some of the High Throughput analytical platforms such as: HPLC/UPLC, GXII Touch, P800, Octet, Peggy Sue, iCE3, Maurice, RT-qPCR, ELISA, Flow cytometry and cell- based functional/ potency assays
Hands-on experience with robotic liquid handers and their operating software to write programs such as Hamilton, TECAN, BRAVO, Ep-Motion, JANUS and others.
Demonstrated prior experience involving developing assays either manual or automated mode by employing some of the analytical platforms and assays including LC, CE, ELISA, PCR, Flow Cytometry, and cell-based assays
Proven understanding with the culture of multiple mammalian cell types
Ability to use literature to design proof of concept studies
Experienced writing technical documents including development reports, qualification protocols and qualification reports.
Excellent communication and presentation skills with the proven ability to solve complex problems and to work effectively as a member of a multidisciplinary team, detail oriented, multitasking, goal and timeline oriented, and critical thinker.
Preferred:
2+ years of relevant industry experience in the biologics or cell and gene therapy space preferred
Experience in Hamilton robotic liquid handlers, automated data analysis, and software such as excel-macros and spotfire.
Expertise in PCR, ELISA and Flow Cytometry techniques and platforms.
Experience with sample management and ELN/LIMS systems
Background in pluripotent stem cells and directed differentiation, AAV, blood cells and/or Crispr-Cas9 systems.
Background in pancreatic islet biology, muscle biology, and/or hematology
