Scientist

Location
Concord, CA
Posted
Sep 07, 2018
Discipline
Science/R&D
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Cerus Corporation is seeking a highly motivated and skilled Scientist to join our Hematology team.  The Scientist will initiate, direct and execute research and Phase I studies to support the INTERCEPT Blood System for Plasma and Platelets marketed products and products in development.  He/she will collaborate closely with other departments internally and with external collaborators at various US Blood Centers to achieve department and corporate goals.                      

Primary Responsibilities:

  • Serve as a Study Director overseeing the study from its conception to completion: study design, protocol preparation, study execution, data analysis, and report preparation.
  • Design and manage research and Phase I in vitro studies for INTERCEPT Blood System for Plasma and Platelets marketed products, and products in development. Assist with preparation of regulatory submissions.

  • Develop relationships with investigators at various US Blood Centers and assist with the accurate implementation of the INTERCEPT for Plasma and Platelets and the conduct of the external registration studies.

  • Be able to analyze complex data, identify trends and aberrations in data, develop solutions, and report results in a clear and impactful manner to drive project completion.

  • Serve as a scientific and technical expert on project teams in the areas of transfusion medicine, hematology, and clinical trials, by contributing ideas and strategies, developing and executing plans, and reporting activities and results.

  • Work cross-functionally with various departments, including Regulatory, Quality, Biostatistics and Clinical.

  • Develop, validate and implement new biochemical and analytical methods and technologies for project advancement.

  • Demonstrate strong organizational, problem solving, communications, and project management skills. 

  • Be creative, results driven, adaptable, and able to influence individuals and teams towards timely completion of company goals.

  • Maintain a high level of professional expertise by staying current with the scientific literature, FDA and EMEA regulatory requirements, company quality and compliance requirements, and GLP, GCP, GMP, ISO/QSR, MDD guidelines.

  • Train, mentor, and/or provide guidance to lab assistants, research associates, or assistant scientists.

    Qualifications/Requirements/Skills: 

  • Ph.D. in a biology-related discipline preferred with a minimum of 2 years relevant experience or MS/MA in a biology-related discipline with a minimum of 8 years relevant experience; BA/BS required with a minimum of 11 years relevant experience.

  • Strong scientific background in the areas of hematology, hemostasis/coagulation, and transfusion medicine is desirable.

  • Experience in early or late-stage product development in a Medical Device, Pharma, or Biotech company is desirable.

  • Experience in writing manuscripts, reports, and/or documentations for regulatory submissions.

  • Experience with GLP, GMP, and GCP regulations is desirable.

  • Excellent problem solving, analytical, scientific, and computer skills.

  • Able to adapt to changing priorities, and demonstrate strong organizational and prioritization skills.

  • Able to support and lead multiple projects simultaneously.

  • Demonstrate initiative, dedication, and ability to work independently and as part of a cross-functional team.

  • Excellent communication skills (verbal, written, interpersonal).

  • Able to travel domestically (10%).

More searches like this