Title: Senior Bioanalytical Scientist
Type: 1+ Year W2 Contract
Location: Remote, candidate can sit anywhere in the U.S.
A mid-sized biotech is seeking a contractor Senior Scientist with a strong background in Bioanalytics to work on a long term (1+ year) contract. This individual will oversee the development, execution, and reporting of bioanalytical analyses, including contribution to regulatory documents, and will work cross functionally to ensure reliable data are provided to end-users in accordance with GXP requirements. Please note that this is a fully remote opportunity.
- Responsible for developing bioanalytical methods to support large and small molecule clinical candidates and providing bioanalytical input across all functional areas and stages of research and development.
- Responsible for coordinating method development and analysis activities within the context of development plans.
- Performs troubleshooting and evaluation of a variety of complex methods to identify appropriate bioanalytical solutions.
- Responsible for leading technology transfer of bioanalytical methods, as appropriate.
- Responsible for review and approval of data and reports from external vendors.
QUALIFICATIONS AND EXPERIENCE:
- PhD with 0-8+ years /MS and 3-8+ years/BS and 5-10+ years of industry experience preferred. (A PhD. is strongly preferred)
- A good combination of laboratory and project management skills (managing CROs/CTLs for assay development and validation for clinical and non-clinical studies)
- Proven expertise in GLP and GCP compliance of sample handling and storage
- Bioanalytical assay development, sample analysis, and laboratory operation and procedures/processes is required.
- Technical expertise with a wide variety of platforms to analyze all aspects of large molecule therapeutics, including those with complex sample handling and preparation procedures (e.g., enzymatic assays, ligand-binding assays, cell-based assays, etc.) from a variety of biological matrices (e.g., serum, plasma, etc.). Small molecules expertise is a plus.
- Familiar with PK and PD principles pertaining to establishment of relevant assays and assay ranges.
If you are interested in this Senior Scientist position, please do not hesitate to apply!!!