Senior Scientific Researcher
1 DNA Way South San Francisco, CA 94080
Bayside Solutions is seeking a Senior Scientific Researcher (SSR) – Technical Oversight of Outsourced Methods to be part of our client’ s team in South San Francisco. 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.
Senior Scientific Researcher (SSR)
- 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:
- This position will support the BioAnalytical Sciences (BAS) organization by providing technical oversight of clinical and non-clinical bioanalytical methods (LC-MS/MS, ligand binding assays (LBA), new technologies (Singulex, Quanterix, Gyros)) supporting pharmacokinetic, toxicokinetic, pharmacodynamic, immunogenicity, and biomarker analyses outsourced to Contract Research Organizations (CRO). The SSR will also review bioanalytical clinical and non-clinical study data generated at the CRO.
- The Senior Scientific Researcher will support research and development projects by:
- Being the front line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (LC-MS/MS, LBA, new technologies) and any technical questions that arise around clinical, non-clinical study data.
- Technical oversight of outsourced methods (LC-MS/MS, LBA, new technologies) ensuring the qualified/validated state to ensure optimal assay quality
- Monitor assay performance through data analysis and interpretation.
- Communicate and present assay performance data and interpretation on an on-going basis to stake holders
- Oversee incorporation and expiration extension of reagents by reviewing and approving assay data and associated documents
- Designing and reviewing in-study validation experiments.
- Review CRO method validation reports and addendums
- Lead investigation of assay performance
- May generate anti-therapeutic antibody cutpoint factors using the ATA cutpoint tool using CRO data for immunogenicity methods.
- May coordinate cross validation experiments at CROs and generate cross validation reports.
- Review of clinical and non-clinical study data.
- Review CRO bioanalytical reports.
- Lead investigation of unexpected study data.
- May write or contribute to sections of Regulatory Documents (IND, BLA, variations, line extensions etc.)
- May serve as a functional area project representative
- The individual will maintain appropriate regulatory compliance in supporting clinical and non-clinical assays and studies, and will apply thorough and accurate documentation skills. The Senior Scientific Researcher may train others on group responsibilities and systems. S/he may also be responsible for implementation or maintenance of support systems and may lead department teams charged with improving business processes.
Summary of Qualifications:
- Bachelor’ s degree or higher in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience 5-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO).
- Familiarity with bioanalytical method GxP compliance is required.
- The SSR will be required to have a proven technical background in developing, validating, implementing, maintaining, and troubleshooting/problem solving abilities of bioanalytical methods in one or more of the following areas: LC-MS (liquid chromatography and mass spectrometry), LBA (PK and ATA), and new technologies.
- Specific to LC-MS, it is desirable for the SSR to have experience with quantitative small molecule and/or protein analysis with mass spectrometric assays. Excellent communication, interpersonal and organizational skills are essential.
- This individual should be able to work independently as well as in a group setting, multi-task and prioritize work well.