Research Associate I, BioAnalytical Testing
791 Lincoln Avenue San Rafael, CA 94901
Bayside Solutions is seeking a Research Associate I, BioAnalytical Testing to be part of our client’ s team in San Rafael. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Research Associate I, BioAnalytical Testing
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- BioAnalytical Sciences develops analytical methods for detection of drug, antibodies to protein therapeutics, and biomarkers in biological matrices from non-clinical and clinical subjects to support projects through multiple stages of development.
- The Research Associate I will perform bioanalysis, using validated PK or immunoassay methods, on non-clinical and clinical samples in a GLP compliant environment. Responsibilities can include sample preparation, sample analysis, GLP documentation, report generation, assay validation and troubleshooting, and interaction with GLP quality assurance unit.
- Responsible for efficient and effective laboratory operations, the Research Associate I has a significant impact on the company' s ability to reach project goals in a timely manner with respect to delivery of data to support pre-clinical and clinical studies critical to advancing programs through the development process.
- Perform quantitative and semi-quantitative assays on non-clinical and clinical samples such as but not limited to serum, plasma, and urine, including immunoassays (ELISA) for therapeutic protein concentration and antibodies to therapeutic proteins, enzymatic activity assays, and glycosaminoglycans determinations.
- Assist in assay development and qualification of new test methods.
- Prepare SOPs, reports and documents such as assay validation, qualification and maintenance reports.
- Independently perform routine tasks with minimal supervision.
- Ensure GLP-compliant sample handling, assay performance and laboratory operations through adherence to SOPs and departmental practices.
- Participate in internal and external inspections/audits.
- Work Environment/Physical Demands:
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
- 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.
Summary of Qualifications:
- Preferred: Bachelor’ s degree or equivalent experience with clinical assays or other quantitative analytical methods in a biological or biochemical field.
- Required: At least 0-2 years of experience in a bioanalytical laboratory, research laboratory, or biotechnology company performing bioanalytical assays.
- Preferred: Skills with ELISA and other analytical methods in a GLP-compliant environment, or equivalent analytical experience in a regulated lab environment.
- Preferred: Experience with GLP or GMP documentation and testing.
- Preferred: Experience with Meso Scale Discovery (MD) and Molecular Devices plate readers.
- Preferred: Experience with Watson LIMS, statistical analysis software, JMP and ELN.
- Preferred: Excellent writing and verbal communications skills.