Sr. Platelet & Plasma Biology Manager (onsite)

Position Description:

Design and oversee execution of experiments or studies; analyze data. Supervise scientific staff, including monitoring deliverables, training, mentoring and performance management. Act as study director for regulated studies. Work performed may support product claims and regulatory submissions. Note trends and aberrations in data, identify problems and suggest/conduct experiments to determine root cause and develop solutions. Develop, validate and implement new analytical methods and technologies for project advancement. Act as principal investigator in designing, conducting and analyzing own experiments. Reduce and analyze highly complex data and present it to maximize clarity and impact. Participate on project teams, contributing ideas, developing plans and supporting execution of plans and timely reporting of results. Maintain laboratory notebooks. Maintain high level of professional expertise through familiarity with scientific literature and attendance at scientific meetings. Write and submit abstracts to national and international conferences and contribute to scientific publications. Perform other related duties as required.

Requirements: Master's degree in Biotechnology or related technical degree with a minimum of 8 years' experience or a PhD in Biotechnology or related technical degree with 5 years of experience.

Academic and/or work experience must include the following:

• Familiarity with ISO 13485 and GLP/GMP regulations & record keeping;
• Assay validation; and
• Understanding of the design phases for product development.

Predicted SOC Code: 19-1042.00 Medical Scientists, Except Epidemiologists

• Level: 4
• Salary Range: $161,000 - $191,000

POSTING NOTICE: This notice is being posted in connection with the filing of a permanent, alien labor certification application. Any person may provide documentary evidence bearing on the application to the U.S. Department of Labor.

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Office of Foreign Labor Certification