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Manager, Reagent & Kit Development

Company: Stealth Mode Startup
Location: Newark
Posted on: January 11, 2022

Job Description:

High growth, pre-IPO company in stealth modeJoin a rapidly growing company that is developing ground-breaking genomics technologies that will push the boundaries in the clinical, life sciences research and therapeutic fields. We are well-funded by global top-tier investors, including venture capital firms and growth equity investors. Our team brings together unique and diverse expertise across multiple disciplines, from healthcare and life sciences, to engineering, to technology and software and beyond. We are a collaborative group of more than 200 employees, including successful entrepreneurs, hardware and software engineers, genomics and biotechnology experts, molecular and computational biologists, software and algorithm experts, and operations and commercial leaders. Play an important role in the development and commercialization of technology and products that will accelerate our understanding of life, biology and disease and transform large industries.We are looking for a highly motivated Manager, Reagent & Kit Development to join our team!How You'll Contribute

  • Manage a pilot manufacturing & quality team to ensure manufacturing & QC robustness for new formulations and kit configurations
  • Serve as bridge between R&D teams and Consumable Manufacturing/Operations
  • Interface and coordinate with R&D, Engineering, Product, and Platform Development teams to ensure project activities are on time and meet performance goals
  • Drive NPI (New Product Introduction) process for reagents and consumables
  • Prepare thorough documentation and SOPs for manufacturing team
  • Facilitate risk assessment (FMEAs) and guard banding
  • Develop QC/inspection strategy including techniques/methods used, sampling size, release specifications, failure testing, etc.
  • Oversee practical process improvements (PPI), identify and drive cost-savings opportunities
  • Lead continuous improvement and sustaining efforts for products and processes in support of cost and performance objectives
  • On-market product sustaining activities include troubleshooting quality issues, root-cause analysis and implementing corrective actionsQualifications, Skills, Knowledge & Abilities
    • BS or MS degree in biochemistry, chemistry, chemical engineering, bioengineering, or closely related field
    • Minimum 7-8 years of related industry experience, including R&D transfer
    • Minimum of 1-2 years of managerial experience
    • Experience with reagents, and functional/analytical assays to qualify and evaluate reagent performance
    • Demonstrated leadership experience, ability to effectively train and motivate a team while instilling a culture of high standards and productivity
    • Collaborates effectively with other teams, strong interpersonal and communication skills
    • Meticulous, detail-oriented, dependable
    • Excellent organizational and time management skills
    • ERP/PLM experience
    • Demonstrated ability to work well in a fast-paced environment, positive can-do attitude
    • Ability to rapidly identify, adapt and respond to changes in environment and priorities#HPWe provide equal employment opportunity for all applicants and employees. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, gender expression, national origin, ancestry, citizenship, age, physical or mental disability, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information, or any other basis protected by applicable laws.

Keywords: Stealth Mode Startup, Newark , Manager, Reagent & Kit Development, Executive , Newark, California

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