Scientist II - Diagnostic Product Development (#0070) Singulex
THIS JOB HAS EXPIRED Summary
Supports the Diagnostic Product Development team. This is a hands-on bench level laboratory position. Tasks will include, but are not limited to: assay feasibility, assay development, optimization, reagent formulation, guard band and stability studies, preclinical assay performance studies, verification and validation studies.
Demonstrates an in-depth understanding of the technology encompassed in and practiced with the Singulex assays as well as general immunoassay principles. Applies knowledge of scientific principles and concepts to the design, development, and execution of Product Development experiments. Demonstrates technical proficiency, scientific creativity, collaboration with others and can work independently. Demonstrates expertise with the Singulex technology and components involved in the Singulex immunoassay system.
Operates lab instruments according to procedures. May write operational procedures for new instruments. Prepares reagents as required.
Analyses human specimens (blood, serum, and plasma) for specific analytes using Singulex or other immunoassays.
May be required to work non-standard hours; for example, second shift, some weekends.
Under minimal guidance of senior personnel designs and conducts research and/or product development, assay optimization and scale-up tasks and experiments based on the needs of the group effort. May also be involved in planning and execution of experiments that support feasibility investigations for newly proposed projects.
Critically analyzes, summarizes and reports data generated from experiments, draws conclusions from experimental results, recommends and executes follow-up actions with consideration of prior experimental findings (self and others) with minimal supervision. Proposes new investigations based on experimental findings. May work on independent projects.
Presents data at Team meetings or to small focus groups that may include representatives from other departments and/or outside parties. Participates in and may 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.
Ensures compliance with and helps to 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). Follows the Singulex Design Control process for Product Development, and documents all work as required by this process. As part of a team effort is involved in the planning, and performs and documents 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. May generate, document and review studies related to verification, validation, and transfer of developed products.
Facilitates the transfer of Product Development processes to Manufacturing, 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.
Maintains familiarity with current technology related information, literature and theories.
Demonstrates scientific creativity and understanding of the principles, requirements and practices of Product Development. Conducts 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.
Trains individuals from own and other departments in laboratory procedures and processes as required.
Helps to coordinate general laboratory tasks such as reagent preparation, inventory, laboratory clean up and organization of work. Performs other duties and assumes additional departmental responsibilities as required. Performs other assignments and tasks as directed.
Normally receives no instructions on routine work, general instructions on new assignments, and detailed instructions or training on new applications or responsibilities.
Works on assignments of a diverse scope in which analysis of situations or data requires an evaluation of various identifiable factors.
BS, MS, or PhD in Biological Sciences (e.g. biology, biotechnology, immunology, cell biology, biochemistry).
Two+ (PhD), Eight+ (MSc), 11+ (BSc) years industry experience in a regulated environment (In-Vitro Diagnostic (IVD) and immunoassay development experience preferred).
Experience with transfer of IVD?s from Product Development to Manufacturing/Operations desired.
Working knowledge of immunoassay methods used for protein analysis, with experience in at least one of the following assay formats: EIA, bead (e.g., Luminex platform), ECL, or ELISA.
Working knowledge of statistics, Design of Experimentation (DOE), the Six Sigma method, risk analysis (FMEA, Cause and Effect, Fishbone Diagram, etc.).
Understanding of Good Laboratory Practices (GLP), Quality Systems Regulations (QSR), and International Organization for Standardization (ISO) regulatory requirements for IVD products 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.
Excellent cross-functional team participation skills.
Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communication.
Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
Ability to inculcate the Singulex ?Top-5? core values and serve as positive example to team members and others within the organization.
Effective personal communication skills, shares knowledge with excellent training skills.
Having integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work with minimal supervision as a member of a team.
Commitment to quality.
Enthusiasm, attention to detail, the ability to meet aggressive deadlines, ability to think ?out of the box,? and ability to work effectively with others in a fast paced, highly-productive environment.
||Alameda, CA |
THIS JOB HAS EXPIRED