Scientist

Rani Therapeutics
San Jose, CA Full Time
POSTED ON 5/6/2023 CLOSED ON 12/18/2023

What are the responsibilities and job description for the Scientist position at Rani Therapeutics?

Job duties – Provide expert in vitro and ex vivo experimental support from concept, design, initiation, execution and data analysis, and communicate results to project teams. Perform bioanalytical assays for the quantification of analytes in preclinical and in vitro samples. Design and manage the data from complex experiments including preliminary statistical analysis, as well as maintain laboratory equipment, supplies, assay operations notebooks, and computer files. Participate in research meetings, including the development of detailed scientific presentations. Support regulatory efforts through understanding of relevant standards and interpretation of FDA guidance documents, and author and execute test protocols for new methods. Perform validation of new assays as well as pre-validation studies, including authoring the validation plan and validation protocols, executing protocols, and preparing validation summary reports. Execute methods for testing the intake process and finished product. Supervise the work of junior staff including technicians, when appropriate. Peer review the work of other scientists in the department to ensure that quality standards are met. Participate in relevant scientific conferences and workshops, and keep up to date with relevant scientific and technical developments. Supervise up to 2 direct reports (Scientists).
Education & Experience required – Master’s degree in biochemistry, bioanalytical chemistry, or related field and 4 years of experience as a bioanalytical scientist. [OR: PhD degree and 2 years of experience]
Background – Experience above must include 2 years with designing and conducting in vitro and in vivo studies to assess drug pharmacokinetics (PK) and pharmacodynamics (PD). Experience above must include 2 years developing and validating bioanalytical assays (including ligand binding assays) for quantitation of drugs and biomarkers in one of the following biological samples: whole blood, serum, plasma, or tissues. Experience above must include 2 years using UV and fluorescence plater readers, and liquid handling robots. Experience above must include 2 years with PK and PD data analysis using one of the following: WinNonlin, GraphPad, or SoftMax Pro Software. Experience above must include 2 years authoring and reviewing nonclinical and clinical sections of regulatory filings. Experience above must include 2 years establishing GLP (Good Laboratory Practice) laboratories according to regulatory and GLP requirements. Experience above must include 2 years collaborating cross functionally, including with Process/Engineering Development, Formulation/Drug Product Development, Manufacturing, Quality Assurance, and Regulatory Affairs teams.
Location – San Jose, CA
Rate of pay – $142,000 to $172,000 per year
How to apply – by email to sohail@ranitherapeutics.com with job ref #S23 in subject heading.

Salary : $142,000 - $172,000

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