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Assay Development Manager Jobs in California (NOW HIRING)

The Manager, Process Development will oversee tech transfers, process improvements and best ... Previous experience with assay development and/or QC strongly desired. * CLIA/FDA laboratory ...

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Assay Development Manager information

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 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?

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 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:
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What cities in California are hiring for Assay Development Manager jobs? Cities in California with the most Assay Development Manager job openings:

Scientist III, Research and Development

Thermo Fisher Scientific

West Hills, CA

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 12 days ago


Thermo Fisher Scientific rating

7.7

Company rating: 7.7 out of 10

Based on 423 frontline employees who took The Breakroom Quiz

197th of 538 rated manufacturers


Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:

How you will make an impact:

As a Scientist III, you will lead technical projects focused on HLA antigen characterization, cell-based assay development, recombinant protein expression, and product quality improvement. Working in a multidisciplinary environment, you will design and execute experiments, analyze complex datasets, troubleshoot technical challenges, and drive continuous improvement initiatives supporting both commercial products and new product development.

This role offers opportunities to collaborate across Cell Biology, Biochemistry, Manufacturing, and Product Development teams while independently leading scientific investigations that directly impact product performance, customer satisfaction, and future innovation.

Location: West Hills, CA. Relocation assistance is NOT provided. 
 

What you will do:

  • Design, execute, and analyze experiments for HLA antigen characterization and cell-based assay development projects
  • Develop and optimize recombinant protein expression systems using mammalian cell culture and stable cell line generation
  • Perform molecular cloning, plasmid construction, and cell transfection to support protein engineering initiatives
  • Conduct flow cytometry analysis and immunological assays to evaluate product performance and quality metrics
  • Characterize proteins using Western blotting, ELISA, immunofluorescence, and other biochemical techniques
  • Troubleshoot technical challenges in assay development and manufacturing support activities
  • Analyze complex biological datasets using statistical software and present findings to cross-functional teams
  • Maintain detailed laboratory documentation in compliance with GMP, GLP, and Design Control standards
  • Collaborate with Cell Biology, Biochemistry, Manufacturing, and Product Development teams on continuous improvement initiatives
  • Support new product development and commercialization activities through technical investigations
  • Contribute to scientific publications, presentations, and intellectual property development
  • Mentor junior scientists and provide technical guidance on specialized techniques

REQUIREMENTS

How you will get here:

  • Advanced Degree with 3+ years of relevant industry or academic experience. Masters Degree required, PhD preferred.
  • Preferred fields of study: Immunology, Cell Biology, Molecular Biology, Biochemistry, Biomedical Engineering, Biotechnology, or related life science discipline.
  • Hands-on experience with mammalian cell culture, recombinant protein expression, and stable cell line generation.
  • Experience with molecular cloning, plasmid construction, DNA manipulation, and mammalian cell transfection.
  • Strong experience developing and optimizing cell-based assays and immunological assays.
  • Proficiency operating flow cytometers (BD, Cytek, Thermo Fisher Attune, or equivalent) and analyzing data using FlowJo or equivalent software.
  • Experience with protein characterization techniques including Western blotting, ELISA, immunofluorescence, immunoprecipitation, or related methods.
  • Strong analytical and problem-solving skills with demonstrated ability to design experiments, troubleshoot technical challenges, and interpret complex biological data.
  • Experience with statistical analysis software (GraphPad Prism, JMP, R, or equivalent) is preferred.
  • Experience supporting assay development, product development, or process improvement in a regulated environment is preferred.
  • Knowledge of HLA biology, immunology, transplant diagnostics, Luminex technology, or flow cytometry-based immunoassays is highly desirable.
  • Experience with gene editing technologies (CRISPR/Cas9) or viral vector-based cell engineering is a plus.
  • Demonstrated ability to independently manage multiple technical projects while collaborating effectively with cross-functional teams.
  • Excellent laboratory documentation skills with attention to detail and familiarity with GMP, GLP, or Design Control documentation practices.
  • Strong written and verbal communication skills with the ability to present scientific findings to multidisciplinary audiences.
  • Track record of scientific contributions through publications, presentations, patents, or successful product development projects is preferred.
  • Excellent organizational and time management skills with the ability to prioritize multiple projects in a dynamic environment.
  • May require up to 20% travel.
  • English language proficiency required; additional language proficiency is beneficial.
  • Must be legally authorized to work in the United States without sponsorship. 
  • Must be able to pass a comprehensive background check, which includes a drug screening.
     

Compensation and Benefits

The salary range estimated for this position based in California is $91,700.00–$137,525.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards


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