Job Details

ID #45327340
State California
City Alameda
Job type Contract
Salary USD Depends on Experience Depends on Experience
Source Oxford Global Resources
Showed 2022-08-31
Date 2022-08-12
Deadline 2022-10-11
Category Et cetera
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Bioanalytical Sr. Scientist (PK and ADA)

California, Alameda, 94501 Alameda USA

Vacancy expired!

Job Title: BioAnalytical Sr. Scientist

Location: Alameda, CA. 90% On-site, some remote may be allowed

Start Date: Client has approval to fill this spot, ASAP.

Length of Contract: 6 - 12 months; potential contract to hire.

Interview Process: One round with CM and two team members, Zoom Interviews.The Bioanalytical Sr. Scientist will report to the Bioanalytical Senior Manager and will be responsible for the development and validation of Ligand-Binding Assays (LBA) for pharmacokinetic (PK), toxicokinetic (TK), biomarkers (PD) and anti-drug antibodies (ADA) and to support sample testing for nonclinical GLP and clinical studies. In addition, the Sr. Scientist will be responsible for:

Responsibilities and Authority

1st Preference: Prior experience with Pharmacokinetic (PK) and/or Anti-drug Antibodies (ADA),

2nd Preference if you don’t have

both of

1st preference: ELISA, Ligand-Binding Assays (LBA), Toxicokinetic (TK), Biomarkers (PD), and Nonclinical GLP
  • Independently develop and validate Bioanalytical Ligand-Binding Assays(LBA) for pharmacokinetic (PK), toxicokinetic (TK), biomarkers (PD) and anti-drug antibodies (ADA) and to support sample testing for nonclinical GLP andclinical studies.2. Work independently with little guidance developing and following writteninstructions and plans work schedules to meet goals.3. Responsible for data analysis and interpretation of multiple assays, andprovide data summaries for method development, validation and sampletesting.4. Implements state-of-the-art technology to develop processes and analysis.5. Write, approve and executes Standard Operating Procedures (SOP),protocols, assay procedures and reports.6. Perform routine analysis on a wide variety of samples.7. Must be detail-oriented and must possess excellent record-keeping andstrong organizational skills.8. Assist with the management of the lab. This includes ensuring compliance ofinstruments, ordering of lab supplies, upgrade of equipment, reagentinventory, and other tasks as necessary.9. Prepare buffers and other reagents and solutions and maintenance oflaboratory equipment.10. Document all work in lab notebooks or assay worksheets, followingestablished site standard operating procedures and adhere to site Qualitysystem standards and applicable company policies/guidelines.11. Ability to work in a collaborative work environment with the bioanalyticalteam. Function effectively in a team-oriented atmosphere and workindependently when necessary.12. Review and check data generated from other staff as assigned.
  • Minimum Reqt’s
  • BA/BS and at least 15 years of relevant laboratory experience, MS or PhD inBiological Sciences and at least 5-10 years of relevant laboratoryexperience.14. Experience and knowledge of Ligand-binding assays (e.g., ELISA / MSD)applicable to Pharmacokinetic, Toxicokinetic, Biomarker and Immunogenicitystudies is required.15. Knowledge of GLP regulations and regulatory guidelines is expected.Experience working in a Google Cloud Platform/GLP environment is desirable.16. Must have experience with assay development, validation and sampletesting in support of nonclinical GLP and clinical studies.17. Large molecule experience is desirable.18. Proficient in the use of basic computer applications such as Microsoft Wordand Excel.19. Knowledge of Softmax™ Pro a plus.
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