We are currently seeking qualified candidates for a Senior Scientist role with a global leader in immunodiagnostics. This is a permanent position that will be based out of the Bay Area, California, USA.
PURPOSE
The Senior Scientist role is a hands-on, bench level laboratory position that includes supervising the work of other laboratory scientists and associates. The successful candidate will conduct experiments on patient specimens; analyze human specimens (blood, urine, feces) for specific analytes to monitor and identify microorganisms using both internal and external assay technologies.
RESPONSIBILITIES
- Set up microbiology procedures and ensure a safe and compliant laboratory environment.
- Grow and maintain bacterial, viral, protozoan and fungal cultures.
- Develop, optimize and validate assays for the the Company’s proprietary system and for other platforms as necessary. Optimize new assays, processes and scaling up to achieve commercial levels of stability, robustness, and performance. Develop and execute systems integration plans for the assay involving automation.
- Supervise and train junior personnel; plan and coordinate experiments and review data of junior personnel. May have direct reports and be responsible for mentorship, guidance, and writing performance reviews
- Support assay troubleshooting, root cause analysis, process improvement, reagent formulation, guard band and stability studies.
- Critically analyze, summarize and report data generated from experiments, draw conclusions from experimental results, recommend and execute follow-up actions with consideration of prior experimental findings (self and others) with minimal supervision.
- Propose new investigations based on experimental findings and literature review. May be involved in feasibility studies to define assay parameters and verification and validation studies to support regulatory requirements.
- Demonstrate a comprehensive understanding of the technology encompassed in and practiced with the Company’s assays as well as other external assay platforms, and understand general immunoassay principles. Apply knowledge of scientific principles and concepts to develop assays and processes.
- Demonstrate success in technical proficiency, scientific creativity, collaboration with others and be able to work independently. An emerging leader who demonstrates expertise with the Company’s technology and components involved in the Company’s immunoassay system.
- Present data at team meetings or to small focus groups that may include representatives from other departments and/or outside parties. Participate in and lead brainstorming and troubleshooting sessions.
- May represent the Company in external relationships including communications with instrument manufacturers, suppliers of critical components, potential partners and evaluation sites.
- Ensure compliance with and implement the requirements of working in a regulated environment to assure adherence to various requirements including Design Control, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
- Follow the Company’s Design Control process for Product Development, and document all work as required by this process. As part of a team effort, be involved in the planning, and perform and document verification activities to ensure that newly developed products meet the pre-determined product specifications and all applicable requirements of the Food and Drug Administration (FDA), QSR, ISO, and CE mark. Generate, document and review studies related to the verification, validation, and transfer of assays under development.
- Ensure maintenance of appropriate laboratory records, notebooks, QC and manufacturing documentation as required for self and direct report(s).
- Facilitate the transfer of Assay Development processes to internal Manufacturing and CMOs, including involvement in the completion and release of enabling documentation for newly developed products by ensuring all relevant technical information is incorporated into the appropriate documents
- Maintain knowledge of current technology-related information, literature and theories. Demonstrate scientific creativity, innovation, and understanding of the principles, requirements and practices of Assay Development.
- Conduct project related information searches, literature searches, and may be involved in review for project specifications and initiation. May contribute to scientific publications, posters and conferences, when appropriate.
- Train individuals from own and other departments in laboratory procedures and processes as required.
- Coordinate general laboratory tasks such as laboratory clean-up and organization of work. Prepare reagents as required and maintain laboratory inventory. Perform other duties and assume additional departmental responsibilities as required. Perform other assignments and tasks as directed.
- Operate lab instruments according to procedures and assist in their routine maintenance. Writes operational procedures for new instruments.
- May be required to work non-standard hours; for example, second shift and some weekends.
- Normally receives no instructions on routine work, minimal instructions on new assignments, and detailed instructions or training on new applications or responsibilities.
- Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
EDUCATION, SKILLS & EXPERIENCE
- MS or PhD in Biological Sciences (e.g. microbiology, biotechnology, immunology, cell biology, biochemistry).
- 5+ (PhD), 11 (MSc), years’ experience in a microbiology laboratory and diagnostic product development
- Demonstrated record of competence in performing microbiology assays in a regulated environment is required. Experience with isolating, growing and maintaining bacterial, viral, protozoan and fungal cultures
- Facilitate the understanding and transfer of key diagnostic development processes / products / information into the manufacturing, commercial and regulatory functions.
- Experience with development of IVD’s, CE marking and the 510(k) submission process are desired.
- Strong knowledge of immunoassay methods used for protein analysis, with hands-on experience in at least one of the following assay formats: EIA, bead-based assay (e.g., Luminex platform), or ECL is required.
- Working knowledge of statistics, Design of Experimentation (DOE), the Six Sigma method, risk analysis (FMEA, Cause and Effect, Fishbone Diagram, etc.) is desired.
- Good understanding of Good Laboratory Practices (GLP), Quality System Regulations (QSR), and International Organization for Standardization (ISO) is required.
- Demonstrated proficiency with Excel, PowerPoint, and Word programs is essential.
- Must have excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical scientific information to a wide range of audiences.