Director/Senior Director, Assay Development

Spear Bio Inc.; Woburn (MA); On-site; USD 90,000 - 160,000; Full time

Job summary

Join a rapidly growing startup focused on revolutionizing early disease diagnosis! As the Director/Senior Director of Assay Development, you will spearhead the creation of innovative immunoassays, driving technical advancements and strategic growth. With a strong emphasis on team leadership and collaboration, you'll guide a talented group of scientists in developing groundbreaking solutions that empower clinicians and researchers. This is an exciting opportunity to make a significant impact in the field of healthcare, contributing to the development of ultrasensitive assays that enhance patient outcomes. If you're passionate about innovation and leadership, this role is perfect for you!

Benefits

Competitive Compensation

Stock Ownership

Strong Benefits

Great Work Environment

Qualifications

• PhD with 8-10+ years in ultrasensitive blood-based assays, preferably for neurodegenerative diseases.
• Experience in protein chemistry, assay optimization, and analytical validation.

Responsibilities

• Lead a team in developing ultrasensitive immunoassays for protein biomarkers.
• Manage assay validation and ensure compliance with regulatory standards.

Skills

Immunoassay Development

Protein Chemistry

Analytical Validation

Project Management

Team Leadership

Presentation Skills

Education

PhD in Biochemistry

PhD in Analytical Chemistry

Tools

MSD

Simoa

Luminex

Ella

Job description

Director/Senior Director, Assay Development

Location: Woburn, Massachusetts
Department: R&D
Employment Type: Full Time – Onsite
Minimum Experience: Senior Manager/Supervisor

Spear Bio is a well-funded and rapidly growing start-up headquartered in Woburn, Massachusetts. We are bringing to market a novel wash-free immunoassay platform with unprecedented sensitivity. The company’s commercial focus is dedicated to revolutionizing early disease diagnosis and monitoring by providing scalable, ultrasensitive solutions that enable accurate measurement of low abundant biomarkers, empowering clinicians and researchers to improve patient outcomes and advance global health.

The Director/Senior Director, Assay Development will lead a team in the development and validation of Spear Bio’s next-generation ultrasensitive immunoassays, driving both technical innovation and strategic growth. This role will have cross-functional responsibilities and work closely with other teams within Assay Development, Platform Development, and Product Development. The Director/Senior Director should have an extensive track record developing ultrasensitive, blood-based immunoassays, ideally focused on neurodegenerative diseases, and a deep understanding of protein biology.

Responsibilities:

• Manage and mentor a team of scientists and research associates in designing and developing ultrasensitive immunoassays for various protein biomarkers, especially in application areas like Neurology.
• Lead preclinical and clinical validation of assays, ensuring regulatory and quality standards are met.
• Oversee assay performance data analysis, troubleshoot technical issues, and perform technical documentation prep, including Standard Operating Procedures (SOPs) and validation reports.
• Define and execute an assay development strategy to align with the company’s goals including antibody selection, conjugation chemistries, and data analysis methodologies.
• Work closely with R&D, Product Management, and Commercial teams to align assay development with platform capabilities and market needs.
• Work closely with QA/QC teams to ensure assays meet rigorous quality standards.
• Collaborate with Key Opinion Leaders (KOLs) and early-access customers for feedback and validation.
• Keep up-to-date with advancements in assay technologies and related fields to drive innovation.

Requirements:

• PhD in Biochemistry, Analytical Chemistry, or related life science field with a minimum of 8-10+ years direct industry experience leading a team of scientists in the development of ultrasensitive blood-based protein biomarker assays, ideally for neurodegenerative diseases (e.g., IVD, clinical trials, contract research, or pharma/biotech).
• Prior experience with immunoassay development should include: protein chemistry, antibody screening, antibody conjugation, assay diluent formulation, multiplexing, preanalytical sample processing, scale-up, assay optimization and troubleshooting, analytical validation, and clinical validation.
• Advanced understanding of ligand binding assays and diverse analytical formats and platforms including: electrochemiluminescence/digital ELISA luminescence/fluorometry-based assays and experience with typical analytical systems, (e.g. MSD, Simoa, Luminex, Ella, NULISA, etc.)
• Deep understanding of protein biology will be a plus.
• Hands-on experience leading a team of junior scientists, and providing technical, clinical, and professional development.
• Possess strong presentation and interpersonal skills with the ability to establish collaborative working relationships across cross-functional teams.
• Excellent project management skills with the ability to manage and organize work around multiple and changing priorities.
• Work on site in Woburn, MA 100%.

We offer competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. This is an opportunity to enter a high-growth startup company at an early stage. We are recruiting candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of - and the effort involved in - building an industry-leading company.

Spear Bio Inc. provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.