Manager/Sr. Manager, Reagent and Consumable Development

Company: Clear Labs
Location: San Carlos
Posted on: November 24, 2020

Job Description:

We are seeking a talented and driven Team Lead, Reagents and Consumables to join our dynamic and fast paced start-up. The team lead will have oversight of all reagent and consumable related activities including development, QC, transfer, support and COGS reduction. Requirements TASKS AND RESPONSIBILITIES * Provide leadership and technical direction for the Reagents and Consumables team. * Develop and execute on strategy for scaling and COGS reduction. * Deliver robust, efficient and well characterized manufacturing processes for reagents and kits. * Work with the Product team to ensure reagents and kits meet customer needs. * Overall responsibility for development of new part specification and qualification. * Overall responsibility for development of reagent kit configuration, BOMs, SOPs, and Batch records. * Overall responsibility for development and validation of analytical and functional QC test methods. * Oversee QC testing activities including troubleshooting. * Provide input for manufacturing process validations. * Establish and maintain a stability program. * Create all required documentation per Quality and Regulatory requirements. * Ensure smooth transfer of processes to departments and end users. * Serve as the key technical liaison for reagent vendors and contract manufacturers. * Participate in auditing and qualifications of vendors and contract manufacturers. * Serve as the Reagents and Consumables representative on cross-functional teams. REQUIREMENTS * Ph.D or M.S. in Molecular Biology, Biochemistry or related discipline preferred. * Minimum 3 years of experience as an NPI lead in the life sciences with proven track record of launching robust products. * Minimum 2 years of management experience. * Deep knowledge of biochemistry and molecular biology, particularly as it pertains to nucleic acid manipulation, modification and amplification. * Experience in managing reagent development/manufacturing for in-vitro diagnostic (IVD) devices and being familiar with 510K process is a plus. * Well versed in analytical tools used for assay and reagent development. * Detail-oriented with strong analytical and troubleshooting skills. * Experience with lab automation a plus. * Experience with NGS highly desirable. * Strong interpersonal skills with demonstrated ability to be effective in cross-functional teams. * Process and data driven, with ability to adapt. * Excellent oral and written communication skills. * Strong project management skills and ability to deliver under tight timelines Benefits * 401K * Comprehensive medical, dental, vision, life and disability insurance * 5 hot meals/week * Unlimited vacation days * Organic snacks and fruit on-site

Keywords: Clear Labs, San Francisco , Manager/Sr. Manager, Reagent and Consumable Development, Executive , San Carlos, California