Scientist 1 or 2 - LC/MS Bioanalysis

Location
San Rafael, CA, United States
Posted
Jul 18, 2019
Ref
21333
Required Education
Doctorate/PHD/MD
Position Type
Full time
Title: Scientist 1/2, BARD Employee Type: FTE Location: San Rafael, CA Critical to the success of each new therapeutic, the BioAnalytical R&D group develops and validates novel assays to measure pharmacokinetics, immunogenicity and biomarkers. We are searching for an experienced bioanalytical scientist to develop and validate assays that will impact non-clinical and clinical studies with innovative new technologies and methodologies. This position offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early non-clinical work through all stages of clinical development, including post-marketing work. The successful candidate will interact with Research and Clinical Scientists, PK scientists and toxicologists to advance our most promising pipeline molecules for rare diseases. You will be in a position to apply various platforms that accelerate drug development, while maintaining a critical eye on assay quality and maintaining regulatory standards. Specifically, we are looking for a motivated and driven bench scientist with ≥2 years of LCMS assay development experience, who has a track record for building assays for small molecules, proteins and/or oligonucleotides (drugs, metabolites, biomarkers) that have been critically reviewed by regulatory agencies.

This Scientist position will report to a Director in BioAnalytical R&D, and will have the opportunity to influence the evolution of the BioAnalytical Sciences department in a growing biotech company.

RESPONSIBILITIES

Develop a variety of analytical methods to detect drug, metabolites and biomarkers in biological matrices. Techniques may include (but are not limited to) mass spectrometry, HPLC/UPLC, and proteomics. Present results, conclusions, and implications to BioAnalytical R&D group. May function as the primary Bioanalytical R&D interface to other departments regarding a designated project and present results to project teams. Develops new techniques, or brings in new technology from the outside, to enhance the analytical capabilities of the group. Prepares SOPs and other documents such as validation protocols, validation reports, and data reports for testing results. Share responsibility for lab management duties. Participates and presents data as a member of BioAnalytical teams, and shares responsibility for project milestones. May serve as Principal Investigator for GLP assays, participate in audits and inspections, and adhere to regulatory compliance standards. Independently carry out the aforementioned tasks and plan, implement, and complete significant projects with little supervision. Participates in scientific meetings and produces original peer-reviewed publications. Other duties as assigned.

EDUCATION

Preferred: Doctorate (Ph.D.) degree in Biology, Chemistry or related fields. Established field of expertise in protein chemistry, oncology, immunology, metabolic disease or similar.

EXPERIENCE

At least 2 years of hands-on experience of using the LCMS platform in a biological or biochemical field including ≥1 year of quantitative analytical method development. GLP experience is preferred. Ability to solve moderately complex issues independently. Excellent verbal and written communication skills. Ability to use computer effectively for data analysis.

~BIO