ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Lead efforts to translate research & discovery findings into robustly performing clinical assay and/or kitted products.
• Support product development initiatives to facilitate cost, performance, workflow, and configuration improvements.
• Manage a team of 6 scientists to achieve departmental objectives.
• Responsible for communicating, coordinating, and aligning the Israeli team’s activities with the US-based department head.
• Responsible for the full product development cycle (under Design Control) for RUO and IVD kitted products
• Oversee transfer and scale-up of assays from the development lab into CMO or in-house Manufacturing/QC teams
• The role will require off-site and/or international travel
• Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
• Ensure compliance with Company’s Quality Management System and ensure that all individuals reporting to him/her comply with the Company’s Quality Management System.
• Communicate status updates, resourcing requirements, and plans to stakeholders and executive leadership
• Critical thinker and subject matter expert in PCR and molecular biology-based assays.
• Experience in implementing product development processes with a track record of bringing products to market.
• Represent the company in professional settings (e.g., conferences, meetings, off-site visits).
• Ability to work in a dynamic, multi-national startup environment
• Experienced in product transfer to manufacturing, drafting of technical reports, SOPs, QCPs and regulatory documents
• Team-leader; able to cultivate a highly functional and motivated group of developmental scientists.
• Performs well under competitive timelines and in an independent capacity.
• Capacity to multitask and triage competing priorities.
• Capable of making astute decisions when faced with limited information and ambiguity.
• Ability to effectively communicate (both verbally and written) ideas, concepts, and project related information.
EDUCATION AND EXPERIENCE REQUIRED;
• PhD in a biomedical field
• 5-10 years of post-graduate work experience as a Sr. Scientist/Manager in Product/Tech Development and/or in a research capacity within the Molecular Diagnostics industry.
• Track record of successful product launches within the IVD space
• Experience managing multiple projects and people.
• Postdoctoral research experience is a plus
• Background in cancer biology/genetics is a plus