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Assay Development Manager Jobs (NOW HIRING)

Nanobiosym

Senior Scientist: IVD Assay Developer

Cambridge, MA · On-site

$100K - $136K/yr

Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission * Manage and contribute to regulatory documents * Project management; personnel management skills ...

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How much do assay development manager jobs pay per year?

As of Jun 21, 2026, the average yearly pay for assay development manager in the United States is $71,527.00, according to ZipRecruiter salary data. Most workers in this role earn between $55,500.00 and $93,500.00 per year, depending on experience, location, and employer.

What jobs can I do with molecular biology?

A molecular biology background can qualify you for roles such as assay development manager, research scientist, laboratory supervisor, or quality control analyst. These positions often require skills in laboratory techniques, data analysis, and familiarity with molecular tools like PCR and sequencing. Opportunities exist in biotech, pharmaceutical, and research institutions, often requiring relevant certifications and experience.

What are some common challenges faced by an Assay Development Manager during the early stages of a new project?

One of the main challenges Assay Development Managers encounter in the early phases of a project is balancing the need for high sensitivity and specificity with practicality and scalability. They often need to troubleshoot unexpected assay variability, optimize protocols, and ensure the reproducibility of results under tight deadlines. Additionally, coordinating input from cross-functional teams—such as R&D scientists, quality assurance, and regulatory affairs—can present logistical hurdles. Effective communication and project management skills are essential to navigate these complexities and drive the project forward.

What is an Assay Development Manager?

An Assay Development Manager is a scientific professional responsible for leading the design, development, validation, and optimization of laboratory assays, which are tests used to measure the presence or amount of a substance in biological samples. They manage teams of scientists and collaborate closely with research, quality, and regulatory departments to ensure assays meet scientific and regulatory requirements. Their work is vital in fields such as biotechnology, pharmaceuticals, and diagnostics, supporting drug discovery, disease diagnosis, and product development.

What does an assay development scientist do?

An assay development scientist designs, optimizes, and validates laboratory tests to measure specific biological or chemical substances. They work with techniques such as ELISA, PCR, or spectrophotometry, often using specialized equipment and following regulatory standards to ensure assay accuracy and reliability.

What is the difference between Assay Development Manager vs Laboratory Supervisor?

AspectAssay Development ManagerLaboratory Supervisor
CredentialsBachelor's/Master's in Life Sciences, relevant certificationsBachelor's in Life Sciences or related field, relevant certifications
Work EnvironmentResearch labs, biotech or pharma companiesLaboratories, clinical or research settings
Employer & IndustryBiotech, pharmaceutical, diagnosticsResearch institutions, hospitals, biotech
Primary FocusDesigning and optimizing assays, project managementOverseeing daily lab operations, staff supervision

The Assay Development Manager focuses on designing, developing, and optimizing assays, often managing projects and teams. In contrast, the Laboratory Supervisor oversees daily lab operations and staff, ensuring smooth workflow. Both roles require relevant scientific credentials and work in similar environments, but their core responsibilities differ significantly.

What are the key skills and qualifications needed to thrive as an Assay Development Manager, and why are they important?

To thrive as an Assay Development Manager, you need a strong background in molecular biology, biochemistry, or a related field, typically with an advanced degree and experience in assay design and validation. Familiarity with laboratory automation, data analysis software, and quality management systems is essential, along with relevant certifications like GLP or ISO standards. Strong project management, leadership, and communication skills help drive cross-functional teams and ensure effective collaboration. These competencies are crucial for delivering reliable assays that meet scientific, regulatory, and business objectives.

What does an analytical development manager do?

An analytical development manager oversees the design, optimization, and validation of analytical methods used to assess the quality and safety of products, often in pharmaceutical or biotech industries. They coordinate laboratory activities, ensure compliance with regulatory standards, and utilize tools like chromatography and spectroscopy. Strong leadership, scientific expertise, and knowledge of regulatory guidelines are essential for this role.

What jobs use PCR?

Assay Development Managers and other laboratory scientists use PCR (Polymerase Chain Reaction) to amplify and detect DNA or RNA sequences in research, diagnostics, and biotech industries. These roles often require knowledge of molecular biology techniques, laboratory skills, and familiarity with PCR equipment and protocols.
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Assay Development Manager jobs near you
Senior Scientist I - IVD Assay Development

Senior Scientist I - IVD Assay Development

Alamar Biosciences

Fremont, CA • On-site

$100K - $136K/yr

Other

Posted 18 days ago

Job description

Position Summary 

The Senior Scientist I - IVD Assay Development will lead the design, development, optimization, and validation of in vitro diagnostic assays for clinical applications. This role requires hands-on laboratory work, regulatory compliance, and cross-functional collaboration to ensure successful product development and commercialization. 

Duties and Responsibilities 

  • Develop IVD assays for FDA and other global regulatory approval/clearance 
  • Design and execute experiments to develop IVD assays and establish assay performance specifications (sensitivity, specificity, reproducibility) 
  • Optimize and  troubleshoot assays to meet performance expectations 
  • Transfer assay designs to tech transfer and manufacturing; define QC measures and support scale-up activities 
  • Work closely with Quality, Regulatory Affairs, Engineering/Software, Product Management, Tech Transfer, and Manufacturing to meet program milestones and commercialization readiness 
  • Participate in technical discussions and project meetings
  • Design and execution of verification and validation (V&V) studies, including all testing and documentation 
  • Perform data analysis and generate study reports suitable for regulatory review 
  • Identify and troubleshoot assay or process issues, recommend solutions, and contribute ideas for assay and process improvements 
  • Stay current on relevant technological and scientific advancements through literature review and evaluation of emerging technologies 
  • Perform other duties as required 

Qualifications 

  • Ph.D. or M.S. in Biochemistry, Molecular Biology, Immunology, or related fields. 
  • 5+ years in IVD assay development and validation. 
  • Hands-on experience with immunoassay formats (ELISA, chemiluminescent), and/or molecular techniques (qPCR, sequencing). 
  • Strong knowledge of regulatory frameworks (FDA 21 CFR Part 820, ISO 13485).  
  • Proficiency in data analysis tools (Excel, GraphPad Prism, or statistical software).  

The base salary range for this full-time position is $150,000 - $165,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process. 

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