Partial Job Description
1) Report to the CEO, VP of Lab Operations and R&D
2) Serve as a key partner to senior leadership in overseeing lab and research operations
3) Oversee daily operations of the processing laboratory
4) Supervise scientific staff
5) Retain ultimate responsibility when delegating responsibilities to a designee
6) Develop and oversee laboratory policy and procedures for clinical and research
7) Interact with Medical Director as to policy and procedures
8) Maintain regulatory requirements for State and Federal regulatory bodies in conjunction with Quality Assurance Department
9) Lead all research and development projects to completion which brings a product to market
10) Oversee Laboratory budgetary issues
12) Recommend standards of operation to Medical Advisory Board
12) Maintain strong interaction with CEO concerning laboratory/medical issues
13) Maintain patent portfolio for the organization
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Qualifications / Skills Required
1) Doctorate degree
2) Minimum 10 years of experience in life sciences sector (biotech, pharma, or med device)
3) Experience with patents and regulatory affairs in dealing with INDs, etc.
4) Experience in auditing other processing facilities
5) Strong background in all applicable regulations to include but not be limited to AABB, OSHA and FDA regulations and guidelines
6) Demonstrated record of presentations and publications
7) Demonstrated ability to think strategically, understand and actively contribute to strategic planning and the development of strategic plans consistent with the mission and vision of the organization
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