Director/Senior Director, Assay Development

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

Spear Bio, founded in 2021, is a well-funded and rapidly growing start-up headquartered in Woburn, Massachusetts.  Our proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR), is a novel wash-free immunoassay platform, offering unprecedented sensitivity. We are dedicated to revolutionizing early disease diagnosis and monitoring by providing scalable, ultrasensitive solutions that deliver unparalleled accuracy in measuring low-abundant biomarkers, enabling 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 & Process 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 high performing scientists and research associates in designing and developing ultrasensitive immunoassays for various protein biomarkers, especially in application areas like Neurology.  
• Define and execute an assay development strategy to align with the company’s clinical and commercial goals including antibody selection, conjugation chemistries, and data analysis methodologies. 
• 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 developing and refining Standard Operating Procedures (SOPs) and validation reports. 
• Collaborate closely across 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 renowned industry 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 specializing in the development of ultrasensitive blood-based protein biomarker assays, for neurodegenerative diseases (e.g., IVD, clinical trials, contract research, or biotech) required. 
• 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: electro-chemiluminescence/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.
• Direct experience managing a team of junior scientists and providing technical, clinical, and professional development.
• Strong presentation and interpersonal skills with the ability to establish collaborative working relationships across cross-functional teams and with renowned industry KOLs.
• Excellent project management skills with the ability to manage and organize work around multiple and changing priorities.
• Ability to work onsite 5 days/week in Woburn, MA.

We offer competitive compensation, with meaningful stock ownership, strong benefits, and a great work environment. This is an opportunity to enter an innovative, high-growth startup at an early stage. We are focused on identifying candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of 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.

Spear Bio does not accept blind resume submissions from external recruiting agencies. Any unsolicited resumes or candidate information submitted without prior written agreement will be deemed the property of Spear Bio, and no placement fees will be paid.