Quanterix
Director, Assay Development
Quanterix, Billerica, Massachusetts, us, 01821
Director of Assay Development
Billerica, MA, USA
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 the goal of significantly improving quality of life and longevity.
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 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 the 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 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 the value of the Simoa assay portfolio. Lead, mentor, and inspire a 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 through the Product Development Process and transfer to manufacturing. Drive the 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 teams, 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 diagnostics, 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, and data analysis software are 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 Commitment to Employees:
At Quanterix, our values are based on:
Team ,
Innovation ,
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 successes 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 is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
#LI-Onsite
#LI-JC2 #J-18808-Ljbffr
Director of Assay Development
to join our
Reagent R&D team
in
Billerica, MA . This is a high-impact role with responsibility for leading the 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 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 the value of the Simoa assay portfolio. Lead, mentor, and inspire a 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 through the Product Development Process and transfer to manufacturing. Drive the 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 teams, 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 diagnostics, 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, and data analysis software are 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 Commitment to Employees:
At Quanterix, our values are based on:
Team ,
Innovation ,
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 successes 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 is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
#LI-Onsite
#LI-JC2 #J-18808-Ljbffr