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Director of R&D Reagents – Immunoassay & IVD

Boston

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Our
client is seeking a Director – R&D for Reagents!

Our
client specializes in diagnostic IVD Point-of-Care instruments in blood
management and hemostasis testing. The company holds an excellent employee
retention rate and offers competitive salaries and bonus structures. And this
position allows for expansion and upward mobility in the future- perhaps even
internationally!

Specific
Responsibilities:

The
R&D Director must have experience in Hemostasis or blood-related IVD field.
They will work with a team to plan, design and conduct complex and advanced
experimentation, design and formulate IVD reagents and assays for POC
instruments. The R&D Director will have good experience in design control
and product development of new products as well as supporting existing
products.

  • Scientific lead
    or contributor to projects (research, development, control, analysis) for
    product discovery, development, launch and support
  • Lead
    investigations of on-market product issues; meet specific investigation
    and program objectives
  • Plan, design and
    perform complex experiments and preparations in the laboratory; adhere to
    safety policies and procedures
  • Independently
    compile and analyze data; prepare reports and present suggestions and
    recommendations to management
  • Develop details
    and lead approach assignments with consideration of schedule, cost,
    reliability, simplicity, manufacturing methods and effectiveness
  • Liaise
    cross-functionally and with external contacts; attend and lead meetings as
    necessary
  • Participate in
    planning, leading and defining new systems, processes and/or methods
  • Mentor R&D
    team members. Supervise direct reports in the lab in the execution, design
    and interpretation of experiments.
  • Maintain
    in-depth knowledge of the field of hemostasis and coagulation; keep
    abreast of new developments.
  • Lead scientific
    discussions both internally and externally; contribute to scientific
    publications in peer-reviewed journals, external conferences and/or
    scientific patents where applicable.
  • Ensure and
    maintain compliance with the Company’s quality system requirements through
    training and adherence to policies, procedures and processes

 

Qualifications:

  • Bachelor’s
    degree and relevant postgraduate degree and training (Ph.D. required) in
    IVD and the area of coagulation.
  • Minimum of 10
    years previous medical/in vitro diagnostic research experience required
  • Assay
    development experience in Hemostasis or blood-related IVD field preferred.
    Prior experience in an industrial laboratory setting required and
    experience with coagulation reagents and instrumentation a plus.
  • Thorough
    knowledge of design control processes and familiarity with GMP required.
  • Exceptional
    investigative ability and analytical skills is a must
  • Expertise in
    designing and conducting experiments with antibodies, coagulation proteins,
    platelets, peptides and enzymes is required
  • Must possess an
    understanding of physical and chemical parameters of proteins and lipids;
    knowledge of the stabilization and optimization of activities of proteins
    and enzymes as required
  • Superior
    technical writing and documentation, communication, interpersonal,
    analytical, and presentation skills are essential
  • Computer
    literacy required; knowledge of Microsoft Office (including extensive
    Excel skills) and significant management systems required
  • Must be flexible
    and creative
  • Must be
    self-motivated and have the ability to work with minimal supervision; must
    also be able to work as part of a cross-functional team.