Research Associate II - Diagnostic Product Development (#0072) Singulex
Demonstrates understanding and application of the technology encompassed in and practiced with the Singulex assays as well as basic immunoassay principles in planning and executing experiments. Performs assays and data analysis with moderate supervision.
Operates lab instruments according to established procedures and prepares reagents as needed.
Analyzes 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.
With consultation may begin to design and conduct product development experiments, assay optimization and scale-up tasks as a part of group effort coordinated by senior members of the team. May also, with consultation, be involved in planning and execution of experiments that support feasibility investigations for newly proposed projects.
Analyzes, summarizes and reports data generated from experiments, draws conclusions from experimental results and suggests follow-up actions with consideration of prior experimental findings (self and others) with moderate supervision.
Presents data at Team meetings or to small focus groups, and participates in brainstorming and troubleshooting sessions within a team setting, suggesting solutions to problems.
Ensures compliance with the requirements of working in a regulated environment, assuring adherence to various requirements including Design Control, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). Demonstrates and applies knowledge of basic scientific principles to experimental responsibilities and demonstrates a clear understanding of and begins to apply the principles, requirements and practices of Product Development.
Performs and may be involved in the planning and documentation of 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), Quality Systems Regulations (QSR), International Organization for Standardization (ISO), and CE mark.
As required, assists in the transfer of Diagnostic Product Development processes to Manufacturing/Operations and assists in 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 and/or literature and may conduct individual project related information and literature searches.
Trains others in laboratory procedures and processes as appropriate, providing feedback to Supervisor on training progress.
Performs and takes a leadership role in 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.
Demonstrates strong written and verbal communication skills. Maintains appropriate laboratory records, notebooks, and other formal company documentation, as required. Works under general supervision, receiving minimal instructions on routine work, general instructions on new assignments, and detailed instructions or training on new applications or responsibilities.
Works on directed assignments of a diverse scope in a team environment where analysis and understanding of data requires evaluation of identifiable factors, and exercises judgment within generally defined practices and policies to determine appropriate conclusion and follow up action.
BS or MS in Biological Sciences (e.g. biology, biotechnology, immunology, cell biology, biochemistry).
2 (MSc) ? 5 (BSc) years industry experience in a regulated environment (In-Vitro Diagnostic (IVD) and immunoassay development experience preferred).
Good understanding of immunoassay methods used for protein analysis (i.e. EIA, bead (e.g., Luminex platform), ECL, ELISA).
Must have strong written and verbal communication skills with a good level of computer literacy.
Experience with Excel, PowerPoint, and Word programs.
Clear understanding of the technology and components involved in the Singulex assays.
Excellent cross-functional team leadership and participation skills.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communications.
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.
Possess integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work independently with minimal supervision and 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 |