Director of Assay Development

Quanterix

Posted on: November 26, 2024

Closing: December 26, 2024

Position Type: Full Time

Job Description

Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein detection. This transformative technology aims to enable earlier disease detection, better prognoses, and precise treatments, with goal of significantly improving quality of life and longevity. We are on a mission to change the way in which healthcare is provided by giving researchers the ability to closely examine the continuum from health to disease.
To make this vision a reality, we brought together the most experienced management team, renowned scientists, industry leading investors and expert advisors from around the globe to, to form a collaborative ecosystem, united through the common goal of advancing the science of precision health.
ROLE SUMMARY:
We are looking for an experienced and highly motivated Director of Assay Development to join our Reagent R&D team in Billerica, MA. This is a high impact role with responsibility for leading development of clinically and commercially significant Simoa biomarker assays. The candidate will use technical and managerial skills and experience to lead a high-performing group of Assay Development scientists and to oversee multiple immunoassay development projects for novel biomarkers serving fast-growing market segments.
WHAT YOU’LL DO:
  • Develop best-in-class ultrasensitive immunoassays that increase value of Simoa assay portfolio.
  • Lead, mentor and inspire high-performing team of assay development scientists to meet new product launch and quality objectives for Simoa assays.
  • Manage resources to achieve timely execution of roadmap activities, managing multiple projects simultaneously.
  • Lead risk assessment, mitigation and troubleshooting activities of high technical and logistical complexity.
  • Serve as a subject matter expert within Quanterix for all technical aspects of Simoa biomarker immunoassay development.
  • Collaborate and communicate effectively with cross-functional stakeholders including Program Management, Product Management, Manufacturing, QC and QA to ensure successful assay progress though Product Development Process and transfer to manufacturing.
  • Drive highest possible standards in data quality using scientifically and statistically appropriate data analysis, interpretation, and reporting techniques and tools.
  • Write, review and/or approve Product Requirements, Test Plans and Reports, Data summaries, Technical Protocols and Qualification reports.
  • Provide regular verbal and written updates to key stakeholders and team/s, including project status, progress, risks, and timelines.
  • Maintain and help drive a culture of excellence and continuous improvement within the Assay Development team.
  • Embody Quanterix values of Accountability, Teamwork, Trust and Transparency.
BASIC QUALIFICATIONS:
  • Bachelor of Science degree in a Life Sciences Discipline
  • 6-10 years of immunoassay development experience. (e.g., in vitro diagnostic, clinical trials, contract research, or pharmaceutical/biotechnology).
  • 5+ years of experience managing people and directly leading immunoassay development projects.
PREFERRED QUALIFICATIONS:
  • Expertise in Immunoassay Development: Extensive experience in commercial immunoassay development, including protein chemistry, antibody screening, conjugation to beads, assay diluent formulation, multiplexing, pre-analytical sample processing, assay scale-up, optimization, troubleshooting, and analytical/clinical validation.
  • Thought leadership in protein biomarkers for neurodegeneration, infectious disease, or cancer is strongly preferred.
  • Proficiency in the application of CLSI guidelines, deep understanding of Fit-for-Purpose validation protocols and industry needs, familiarity with ISO 9001/13485 quality systems and FDA data reporting requirements are preferred.
  • Demonstrated success in leading product development through a stage-gate process.
  • Ability to manage multiple projects and priorities while aligning with organizational goals.
  • Exceptional verbal and written communication, with the ability to convey complex technical concepts clearly and proactively to reporting teams and leadership.
  • Strong relationship-building skills with the ability to work effectively across internal teams and external partners.
  • Advanced skills in Microsoft Office, Graphpad Prism, Data analysis software is preferred; experience with document control (e.g., MasterControl) and ERP systems (e.g., Syteline) is preferred.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:

  • Ability to work onsite 5 days a week.

WHY YOU’LL LIKE WORKING WITH US:
Our Technology:
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.

Our Commitment to Employees:

At Quanterix, our values are based on: TeamInnovation, Customer and Owner.
Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards
Innovation: Stay curious, experiment, create and change
Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments
Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.
We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!

DIVERSE & INCLUSIVE WORKPLACE:

Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Quanterix

Posted on: November 26, 2024

Closing: December 26, 2024

Position Type: Full Time

Similar Jobs


Hamilton, Canada

Scientist III, Biology

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical...

South San Francisco, United States

Associate Director, Regulatory Affairs CMC

Support the development of CMC regulatory strategies in collaboration wi...

Bar Harbor, United States

Research Assistant II | Kumar...

Manage and maintain the mouse colony, including breeding, weaning, and h...

Cambridge, United States

Senior Scientist I/II, Rare/Neuromuscular Disease

We are seeking an outstanding candidate to join our Discovery Biology Te...