Scientist II - Alameda, CA | Biospace
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Scientist II

Singulex

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Location:
Alameda, CA
Posted Date:
9/19/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Assay Development, Associate, Elisa, Microbiology, Molecular, Molecular Biology, Research,

Job Description

Corporate Mission



Singulex is a commercial stage, privately held company pioneering Next Generation immunodiagnostics (NGI). Singulex’s provides unprecedented ultra-sensitivity in the precision measurement of biomarkers. Such reliable ultra-sensitive accuracy provides definitive health status answers for physicians and patients resulting in improved health outcomes and reduced healthcare cost, without reducing delivery of care. Powered by SMCTM  technology, the company’s NGI commercial offerings are transforming patient care from reactive disease treatment to proactive health management.

Essential Duties and Responsibilities:

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.
Liases between Assay Development and System Integration teams.
Tasks may include system feasibility studies, liquid handling optimization, assessment of consumables, and performance studies to meet product specifications
May participate in developing and optimizing assay processes with the Singulex System Immunoassay platform.
May execute system-level test plans for use in conjunction with the Singulex System Immunoassay platform.
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.

Requirements

Qualifications:

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.


Responsibilities:

This is a hands-on, bench level laboratory position that includes supervising the work of other laboratory scientists and associates.
Conduct experiments on patient specimens; analyze human specimens (blood, urine, feces) for specific analytes to monitor and identify microorganisms using Singulex or other assay technologies.
Set up a 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 Singulex Clarity® 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 Singulex assays as well as other assay platforms employed by Singulex, Inc., 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 Singulex technology and components involved in the Singulex 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 Singulex 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 Singulex 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 cleanup 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.




Personal Characteristics:

Excellent cross-functional team leadership and 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 communications.
Ability to work in a fast-paced and changing environment
Flexible and quickly adaptable to changing priorities.
Good people skills.  Ability to supervise team members and work with a positive attitude, control negativity, and promote teamwork at all times.
Ability to inculcate the Singulex “Top-5” core values and serve as positive example to team members and others within the organization.
Effective interpersonal communication skills.
Excellent training skills and shares knowledge.
Having 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.