Research Associate I/II, Assay Strategy and Development
Title: Research Associate I/II, Assay Strategy and Development, Bioanalytical Sciences
Employee Type: Full Time, On-Site
Location: United States – San Rafael, California
The BioAnalytical Sciences group generates data to answer key translational questions during the non-clinical and clinical development of new therapeutics. We are searching for a talented and highly motivated laboratory scientist to join our team.
This position offers a unique opportunity to interact with scientific and business colleagues across many functional areas, including Research, Translational Sciences, and Clinical Sciences, to advance our most promising pipeline molecules to treat rare genetic diseases. The successful candidate will participate in programs that progress from early pre-clinical in vitro and animal studies, through clinical trials, interactions with FDA and other global regulators, and post-marketing studies after approval. The applicant will be responsible for developing new analytical tools that generate reliable data from regulated non-clinical and clinical studies, ultimately leading to approval of new treatments for patients with rare genetic diseases.
This Research Associate I/II position will report to a Principal Scientist in Assay Strategy and Development and will have the opportunity to influence the evolution of the BioAnalytical Sciences department in a growing biotech company.
- Working together with research associates, scientists and project leads, develop a variety of analytical methods to detect drug, antibodies to protein therapeutics, and biomarkers in biological matrices. Techniques may include ELISA/ECL, cell-based assays, enzyme activity assays, PCR, qPCR, ddPCR, capillary electrophoresis, western blot, surface plasmon resonance (Biacore), hybridization ELISA, flow cytometry.
- Characterize performance of selected assays and reagents for transfer to the Bioanalysis group within BioAnalytical Sciences or external labs for method validation and regulated study sample testing.
- May participate in method transfer or validation activities or monitor assay performance at external labs during regulated study sample testing.
- Present results, conclusions, and implications to BioAnalytical Teams, Early Development Teams, and other internal and external forums as appropriate, and share responsibility for project milestones
- Prepare SOPs and other reports and documents such as qualification reports, validation protocols, and data reports for testing results.
- Share responsibility for lab management duties
- Participate in scientific meetings and contribute to original peer-reviewed publications.
- Other duties as assigned.
Bachelor’s or Master’s degree in biological / biochemical sciences or related field. Training in analytical techniques such as immunoassays, cell culture, and molecular biology preferred. Working knowledge of cell and molecular biology and biochemistry.
Bachelor’s degree in a scientific discipline or equivalent with 2 to 5 years hands on lab experience, or Master’s degree with 1 to 3 years experience. Track record of success developing analytical techniques that support scientific investigations. Broad technical proficiency. Ability to work independently and in teams. Experience with industry assay development and validation preferred. Excellent verbal and written communication skills. Ability to use computer software effectively for data analysis.
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.