Scientist - Bioanalytical
- Employer
- TrueBinding
- Location
- Bay area
- Start date
- Sep 17, 2020
View more
- Discipline
- Science/R&D, Biomedical Sciences, Pharmacokinetics
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
About TrueBinding Inc.:
TrueBinding Inc., is a biotech startup developing first-in-class immunotherapy antibody drugs to treat cancer, fibrosis, metabolic and neurodegenerative diseases, based on our proprietary TrueBinding platform.
Job Summary:
The successful candidate will play supportive role in preclinical pharmacology group as a bench scientist. The candidate will help to advance programs from discovery to IND filing
Key Responsibilities:
• Develop and qualify fit-for-purpose PK, PD, and immunogenicity assays that meet the needs of the program and perform subsequent analysis of PK/PD study samples
• Summarize bioanalytical results, develop work processes, and write technical reports in support of business development activities and regulatory filings
• Manage method transfer and outsourcing efforts to allow timely bioanalytical support for research and development activities
• Proficiency with PK/PD assessment with multiple techniques including Elisa, Meso scale discovery, flow cytometry, microscopy.
• Working knowledge of PK/PD, ADME, ADA principles and software (e.g. Winonlin, NONMEM, SimBiology etc)
• Proficiency in In-vivo biology skills related with PK/PD/ADME/Tox (small rodent handling, tissue collections, plasma/serum/tissue preparation, etc).
• Participate in regular cross-functional team meetings and function as a strong collaborative colleague
Preferred Education/Experience:
• A Masters/Ph.D. in Biology, Pharmacology, Immunology or a related subject
• Minimum of 3 years industry experience
• Experience developing and/or validating pharmacokinetics, biomarkers and immunogenicity assays
• Experience developing antibody-based therapeutics
• Previous experience managing a CRO is desirable.
• Thorough understanding of the FDA’s and NMPA’s regulatory guidance related to bioanalytical assays
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