The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea ... Provides disease biology expertise to clinical study teams and functional areas such as regulatory ...
The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea ... Provides disease biology expertise to clinical study teams and functional areas such as regulatory ...
Head of Platform Bioengineering & Assay Development
San Francisco, CA · On-site
$200 - $250/hr
... biology from the very first experiment. Our platform is 87% concordant with clinical patient data ... With the FDA Modernization Act 3.0 and the FDA's March 2026 validation framework, the regulatory ...
Head of Platform Bioengineering & Assay Development
San Francisco, CA · On-site
$200 - $250/hr
... biology from the very first experiment. Our platform is 87% concordant with clinical patient data ... With the FDA Modernization Act 3.0 and the FDA's March 2026 validation framework, the regulatory ...
... molecule, biological products, and novel therapeutics (i.e., mRNA). * Manage the lifecycle of ... Develop and maintain procedures and practices in compliance with FDA, EMA, and local regulations ...
... molecule, biological products, and novel therapeutics (i.e., mRNA). * Manage the lifecycle of ... Develop and maintain procedures and practices in compliance with FDA, EMA, and local regulations ...
Head of Platform Bioengineering & Assay Development
San Francisco, CA · On-site
$203K - $229K/yr
... biology from the very first experiment. Our platform is 87% concordant with clinical patient data ... With the FDA Modernization Act 3.0 and the FDA's March 2026 validation framework, the regulatory ...
Head of Platform Bioengineering & Assay Development
San Francisco, CA · On-site
$203K - $229K/yr
... biology from the very first experiment. Our platform is 87% concordant with clinical patient data ... With the FDA Modernization Act 3.0 and the FDA's March 2026 validation framework, the regulatory ...
... two FDA-approved, first-in-class medicines, generating royalties and milestones from global ... to join our Biology and Translational Science team in Early Drug Discovery. The successful ...
... two FDA-approved, first-in-class medicines, generating royalties and milestones from global ... to join our Biology and Translational Science team in Early Drug Discovery. The successful ...
We are seeking a first-rate chemical biologist to help us pioneer this uncharted frontier of drug ... The most common mechanism of action for FDA-approved drugs is inhibition[1], but there are many ...
We are seeking a first-rate chemical biologist to help us pioneer this uncharted frontier of drug ... The most common mechanism of action for FDA-approved drugs is inhibition[1], but there are many ...
We are seeking a first-rate chemical biologist to help us pioneer this uncharted frontier of drug ... The most common mechanism of action for FDA-approved drugs is inhibition[1], but there are many ...
We are seeking a first-rate chemical biologist to help us pioneer this uncharted frontier of drug ... The most common mechanism of action for FDA-approved drugs is inhibition[1], but there are many ...
Senior Research Associate, Biology and Translational Science About Us Protagonist Therapeutics is a ... two FDA-approved, first-in-class medicines, generating royalties and milestones from global ...
Senior Research Associate, Biology and Translational Science About Us Protagonist Therapeutics is a ... two FDA-approved, first-in-class medicines, generating royalties and milestones from global ...
Serve as the primary quality lead for FDA and other health authority inspections and internal ... Help prepare the company for a successful Biologics License Application (BLA), including pre-BLA ...
Serve as the primary quality lead for FDA and other health authority inspections and internal ... Help prepare the company for a successful Biologics License Application (BLA), including pre-BLA ...
Research Associate I
Scotts Valley, CA · On-site
$25 - $27/hr
... and compliance of FDA regulations and guidance. Prepare written research summaries and ... S. in nutrition, food science, biological sciences or related field, or B.S./B.A. with at least 3 ...
Research Associate I
Scotts Valley, CA · On-site
$25 - $27/hr
... and compliance of FDA regulations and guidance. Prepare written research summaries and ... S. in nutrition, food science, biological sciences or related field, or B.S./B.A. with at least 3 ...
Associate Scientific Director, Translational Medicine - Neurology
San Diego, CA · On-site
$200 - $250/hr
The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea ... Provides disease biology expertise to clinical study teams and functional areas such as regulatory ...
Associate Scientific Director, Translational Medicine - Neurology
San Diego, CA · On-site
$200 - $250/hr
The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea ... Provides disease biology expertise to clinical study teams and functional areas such as regulatory ...
Research Associate I
Scotts Valley, CA · On-site
$25 - $27/hr
... and compliance of FDA regulations and guidance. Prepare written research summaries and ... S. in nutrition, food science, biological sciences or related field, or B.S./B.A. with at least 3 ...
Research Associate I
Scotts Valley, CA · On-site
$25 - $27/hr
... and compliance of FDA regulations and guidance. Prepare written research summaries and ... S. in nutrition, food science, biological sciences or related field, or B.S./B.A. with at least 3 ...
Executive Director, GMP Quality Assurance
San Diego, CA · On-site
$270K - $290K/yr
Serve as the primary quality lead for FDA and other health authority inspections and internal ... Help prepare the company for a successful Biologics License Application (BLA), including pre-BLA ...
Executive Director, GMP Quality Assurance
San Diego, CA · On-site
$270K - $290K/yr
Serve as the primary quality lead for FDA and other health authority inspections and internal ... Help prepare the company for a successful Biologics License Application (BLA), including pre-BLA ...
Executive Director, GMP Quality Assurance
San Diego, CA · On-site
$250/hr
Serve as the primary quality lead for FDA and other health authority inspections and internal ... Help prepare the company for a successful Biologics License Application (BLA), including pre-BLA ...
Executive Director, GMP Quality Assurance
San Diego, CA · On-site
$250/hr
Serve as the primary quality lead for FDA and other health authority inspections and internal ... Help prepare the company for a successful Biologics License Application (BLA), including pre-BLA ...
The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea ... Provides disease biology expertise to clinical study teams and functional areas such as regulatory ...
The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea ... Provides disease biology expertise to clinical study teams and functional areas such as regulatory ...
Senior Biocompatibility Scientist II
Santa Clara, CA · On-site
$107K - $146K/yr
Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based ...
Senior Biocompatibility Scientist II
Santa Clara, CA · On-site
$107K - $146K/yr
Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... biologics CMC principles, including development processes, manufacturing, and controls. * Thorough knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and ...
Senior Director, Regulatory CMC
South San Francisco, CA · On-site
$180K - $237K/yr
... biologics CMC principles, including development processes, manufacturing, and controls. * Thorough knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and ...
Senior Director, Regulatory CMC
$180K - $237K/yr
... biologics CMC principles, including development processes, manufacturing, and controls. * Thorough knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and ...
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Senior Director, Regulatory CMC
$180K - $237K/yr
... biologics CMC principles, including development processes, manufacturing, and controls. * Thorough knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and ...
Senior Biocompatibility Scientist II
Santa Clara, CA · On-site
$107K - $146K/yr
Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based ...
Senior Biocompatibility Scientist II
Santa Clara, CA · On-site
$107K - $146K/yr
Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based ...
Senior Biocompatibility Scientist II
Santa Clara, CA · On-site
$150 - $200/hr
Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based ...
Senior Biocompatibility Scientist II
Santa Clara, CA · On-site
$150 - $200/hr
Conduct and document biocompatibility assessments, develop evaluation plans, and prepare reports in compliance with biological evaluation standards and FDA/ISO guidance documents within a risk-based ...
Fda Biologist information
See California salary details
$36.5K - $45.6K
6% of jobs
$45.6K - $54.6K
9% of jobs
$60K is the 25th percentile. Wages below this are outliers.
$54.6K - $63.7K
17% of jobs
$63.7K - $72.8K
13% of jobs
The median wage is $77.8K / yr.
$72.8K - $81.8K
10% of jobs
$81.8K - $90.9K
7% of jobs
$90.9K - $99.9K
12% of jobs
$103.3K is the 75th percentile. Wages above this are outliers.
$99.9K - $109K
4% of jobs
$109K - $118.1K
4% of jobs
$118.1K - $127.1K
1% of jobs
$127.1K - $136.2K
17% of jobs
$36.5K
$88.2K
$136.2K
How much do fda biologist jobs pay per year?
What is an FDA biologist?
An FDA Biologist is a scientist who evaluates biological products, research data, and laboratory studies to ensure public health and safety. They work on regulatory reviews, inspections, and policy development related to vaccines, gene therapy, blood products, and other biologics. Their role helps ensure compliance with federal regulations and supports scientific advancements in healthcare.
What are the typical daily responsibilities of an FDA biologist?
An FDA Biologist’s daily tasks often include reviewing scientific data, conducting laboratory experiments, and preparing reports on biological product submissions. You may assess the safety and efficacy of products such as vaccines or medical devices, ensuring compliance with regulatory standards. Collaboration with interdisciplinary teams—including chemists, statisticians, and regulatory affairs specialists—is common to address scientific questions and support regulatory decision-making. The role also involves staying updated on scientific advancements and regulatory changes relevant to the field. This dynamic environment provides opportunities to contribute to public health while developing specialized expertise.
What are the key skills and qualifications needed to thrive in the FDA biologist position, and why are they important?
To thrive as an FDA Biologist, you need a degree in biology or a related scientific field, strong analytical and laboratory skills, and a solid understanding of regulatory requirements. Familiarity with laboratory instruments, scientific data analysis tools, and regulatory databases such as GLP (Good Laboratory Practice) systems is important. Attention to detail, effective communication, and strong problem-solving abilities are valuable soft skills in this role. These competencies are crucial for accurately evaluating biological data, ensuring regulatory compliance, and collaborating effectively within multidisciplinary teams at the FDA.
What are popular job titles related to Fda Biologist jobs in California?
For Fda Biologist jobs in California, the most frequently searched job titles are:
What job categories do people searching Fda Biologist jobs in California look for?
The top searched job categories for Fda Biologist jobs in California are:
What cities in California are hiring for Fda Biologist jobs?
Cities in California with the most Fda Biologist job openings:

Associate Scientific Director, Translational Medicine - Neurology
San Diego, CA • On-site
Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 12 days ago
Job description
Neurocrine Biosciencesis a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visitneurocrine.com, and follow the company onLinkedIn,X, Facebook and YouTube. (*in collaboration with AbbVie)
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Your Contributions (include, but are not limited to):Establishes translational plans for designated programs and participate with senior management to align biomarker strategies to program goals to enable data-driven decisions
Provides disease biology expertise to clinical study teams and functional areas such as regulatory, clinical development, and clinical operations
Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value mechanistic insight for future critical decisions
Collaborates with external opinion leaders. internal clinicians, research scientists and clinical operations to ensure appropriate biomarkers are incorporated within clinical studies validated appropriately for their intended use
Support identification and development of novel biomarker platforms
Engage with CROs to develop and validate clinical biomarker assays in a fit-for-purpose manner
Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
Reviews and interprets scientific knowledge of competitor landscape (molecule/indication)
Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author biomarker sections of regulatory documents (IB, IND sections)
Remains up-to-date with current information on biomarker regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
Other duties as assigned
BS/BA degree in Biology, Chemistry, or related science field AND 8+ years of relevant experience OR
Master's in Biology, Chemistry, or related science field AND 6+ years of related experience OR
PharmD or PhD AND 5+ years of related experience
Strong knowledge of several areas within experimental medicine and biomarker development with deep expertise in at least one area
Ability to work effectively in cross-functional teams
Skill in evaluating data and data quality from multiple sources
Capable of making data-driven decisions that impact project/program success
Recognized as an emerging thought leader with technical expertise in the field
Experience in immunoassay development and GxP-based biomarker platform deployment
Working knowledge of FDA guidance on bioanalytical method validation and related regulatory aspects
Understanding of biomarker assay validation and lab certification levels to support the intended purpose of clinical assay
Strong grasp of FDA's BEST resource with specific knowledge around surrogate endpoints
Extensive experience working with CROs to support clinical assay development and sample testing
Excellent communication and presentation skills
Experience with regulatory filings and interactions
Demonstrated expertise in Translational Science
Passion and tenacity to advance patient-focused research
#LI-SA1
Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
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The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.About Neurocrine Biosciences
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
San Diego, CA, US
Year founded
1992