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Assay Development Manager information

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 are the key skills and qualifications needed to thrive as an assay development manager?

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 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 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.

How to do assay development?

Assay development involves designing and optimizing laboratory tests to accurately measure specific analytes or biological activities. It requires selecting appropriate detection methods, validating assay performance parameters such as sensitivity and specificity, and ensuring reproducibility. Skills in laboratory techniques, familiarity with instrumentation, and understanding of regulatory standards are essential for successful assay development.

What are the most commonly searched types of Assay Development jobs in California?

The most popular types of Assay Development jobs in California are:

What are popular job titles related to Assay Development Manager jobs in California?

For Assay Development Manager jobs in California, the most frequently searched job titles are:

What job categories do people searching Assay Development Manager jobs in California look for?

The top searched job categories for Assay Development Manager jobs in California are:

What cities in California are hiring for Assay Development Manager jobs?

Cities in California with the most Assay Development Manager job openings:

Assay Development Manager jobs near you

Senior Scientist - Assay Development

Palo Alto, CA • On-site

Guardant Health
Biotechnology Research and Development • 1 - 5K employees

9.4

Company rating: 9.4 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

3rd of 120 rated laboratories

Great coworkers

People enjoy working here

Good employer

Learn more about Guardant Healthexternal

$107K - $146K/yr

Full-time

Posted 5 days ago

Job description

Company Description
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant® is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Profile Summary:
To enable Guardant Health to lead the disruption of cancer diagnostics through non-invasive cancer detection, the Assay Development Team is seeking a highly motivated scientist to develop novel technologies for cancer detection and profiling in a regulated environment. The ideal candidate is passionate about data analysis and troubleshooting and is a team player who excels in a cross-functional environment.
In the Assay Development team, you will collaborate cross-functionally wit∂h members from research, bioinformatics, process engineering, operations, and software. You will lead and analyze studies to further the development of automated molecular assays for the early detection, treatment and monitoring of all cancer types.
An ideal candidate has a strong foundation in molecular and nucleic acid biology, with experience developing automated NGS assays on automated platforms in a regulated environment. Experience with non-nucleic acid bioanalytes is also desirable.
Essential Duties and Responsibilities
  • Develop, test, validate, and improve NGS-based automated assays for oncology and cancer screening diagnostics.
  • Explore and implement new technologies to drive assay innovation and workflow optimization.
  • Integrate analytical tools and experimental design to evaluate performance in a high throughput sequencing sample preparation and specimen handling workflow
  • Collaborate across teams to solve development challenges, improve existing NGS workstreams, and propose/implement solutions.
  • Operate molecular biology laboratory equipment, including automated liquid handlers, quantitation instruments, thermal cyclers, and NGS instruments.
  • Present data, write technical reports and protocols, and communicate findings effectively to both technical and non-technical audiences.
  • Train and support junior team members.
  • Demonstrate strong commitment to delivering results in a fast-paced, dynamic environment at Guardant Health.

Qualifications
  • PhD in Molecular Biology, Genomics, Biochemistry or related field, or equivalent work experience.
  • Requires a minimum of 5-8 years of industry experience developing and validating diagnostic assays.
  • Strong foundation in molecular biology techniques including sample preparation for NGS and other molecular biology workflows.
  • Experience developing assays optimized for implementation on automated liquid handling platforms.
  • Quantitative/analytical mindset - ability to segment complex problems into fundamental parts/basic principles, develop models and experimental tests for those models, and synthesize results into actionable solutions.
  • Demonstrated ability to organize, document and communicate scientific data.
  • Consummate team player: demonstrated ability to thrive in an environment where numerous contributions are required to accomplish complex goals.
  • Enjoy working independently and collaboratively in a fast-paced environment and are able to adapt to changing priorities.
  • Curiosity, drive, and sense of humor.
Preferred Qualifications
  • Experience developing products under design control
  • Experience with data science and statistical analysis tools in Python and/or R
  • Familiarity with oncology or cancer biology

AI & Digital Fluency
  • Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.

Hybrid Work Model:This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.
The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate's compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need.Primary Location: Palo Alto, CAPrimary Location Base Pay Range: $138,400 - $190,300Other US Location(s) Base Pay Range: $117,640 - $161,755If the role is performed in Colorado, the pay range for this job is: $124,560 - $171,270
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to Peopleteam@guardanthealth.com
A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.
Please visit our career page at: http://www.guardanthealth.com/jobs/

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