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Bioanalytical Project Manager Jobs in California

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Sr. Research Associate

Novato, CA ยท On-site

$45 - $51/hr

... on projects * Experience with data management systems, familiarity with data and statistical ... bioanalytical assays

... bioanalysis to support development of novel small molecule therapeutics as detailed below ... managing/coordinating daily lab activities, conducting in vitro ADME assays, cell culture ...

Sr Associate Scientist, Biology

Foster City, CA ยท On-site

$126K - $164K/yr

Manage PK sample analysis workflows across multiple studies * Collaborate with DMPK, biology, and ... Broad knowledge of PK bioanalytical assays, including ADA * Demonstrated ability to analyze and ...

Sr Associate Scientist, Biology

Foster City, CA ยท On-site

$126K - $164K/yr

Manage PK sample analysis workflows across multiple studies * Collaborate with DMPK, biology, and ... Broad knowledge of PK bioanalytical assays, including ADA * Demonstrated ability to analyze and ...

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Bioanalytical Project Manager information

What does a Bioanalytical Project Manager do?

A Bioanalytical Project Manager oversees and coordinates bioanalytical studies, ensuring that projects are completed on time, within budget, and according to regulatory standards. They act as the main point of contact between clients, laboratory teams, and regulatory agencies, managing study timelines, resources, and data quality. Their responsibilities include planning project activities, monitoring progress, troubleshooting issues, and reporting results to stakeholders. They play a critical role in drug development by ensuring that bioanalytical testing meets scientific and compliance requirements.

What are the key skills and qualifications needed to thrive as a Bioanalytical Project Manager, and why are they important?

To thrive as a Bioanalytical Project Manager, you need a strong background in bioanalysis, project management experience, and typically a degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), regulatory guidelines (such as GLP/GCP), and project management tools like MS Project is essential. Excellent communication, leadership, and organizational skills help manage cross-functional teams and client expectations. These skills ensure the successful planning, execution, and delivery of complex bioanalytical projects within regulatory and timeline constraints.

What are some common challenges faced by Bioanalytical Project Managers, and how can they be addressed?

Bioanalytical Project Managers often face challenges coordinating timelines across multiple stakeholders, such as laboratory teams, clients, and regulatory bodies. Managing shifting project priorities and ensuring data integrity under tight deadlines can also be demanding. To address these challenges, effective communication, proactive risk management, and strong organizational skills are essential. Regular status meetings, clear documentation, and building strong relationships with both internal and external partners help keep projects on track and ensure compliance with regulatory standards.

What is the difference between Bioanalytical Project Manager vs Bioanalytical Scientist?

AspectBioanalytical Project ManagerBioanalytical Scientist
CredentialsBachelor's or Master's in Life Sciences, PMP often preferredDegree in Biology, Chemistry, or related field; PhD or Master's common
Work EnvironmentProject teams, client meetings, coordination rolesLaboratory research, data analysis, method development
Employer & Industry UsagePharmaceutical, biotech companies, CROsResearch labs, pharmaceutical companies, CROs

The Bioanalytical Project Manager oversees project timelines, budgets, and client communication, ensuring successful completion. In contrast, the Bioanalytical Scientist focuses on experimental design, data collection, and method development. Both roles are essential in the bioanalytical industry but differ in responsibilities and daily tasks.

What are popular job titles related to Bioanalytical Project Manager jobs in California? For Bioanalytical Project Manager jobs in California, the most frequently searched job titles are:
What cities in California are hiring for Bioanalytical Project Manager jobs? Cities in California with the most Bioanalytical Project Manager job openings:
Infographic showing various Bioanalytical Project Manager job openings in California as of June 2026, with employment types broken down into 93% Full Time, 5% Part Time, 1% Temporary, and 1% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution.
Principal/Senior Scientist, PK/PD Assays

Principal/Senior Scientist, PK/PD Assays

NewLimit

South San Francisco, CA โ€ข On-site

$155K - $200K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 18 days ago


Job description

About NewLimit
NewLimit is seeking a Scientist or Senior Scientist with deep expertise in molecular biology, pharmacokinetics and translational biomarker assay development. In this role, you will lead the design, development, and qualification of pharmacokinetic (PK) and pharmacodynamic (PD) assays that characterize the biodistribution and biological activity of our mRNA-LNP medicines in preclinical and IND enabling studies. You will serve as a technical leader within our bioanalytical function, shaping biomarker assay strategy and partnering cross-functionally to advance our therapeutic programs toward IND-enabling milestones.
What you'll do
  • Own the end-to-end design, development, and qualification of PK and PD biomarker assays across various platforms to support preclinical and IND-enabling studies
  • Discover and validate pharmacodynamic biomarkers to support the clinical development of drugs across multiple programs
  • Drive data analysis, interpretation, and reporting for bioanalytical studies to support program decision-making with audit-ready data packages
  • Contribute to sample processing workflows including tissue harvesting, primary cell culture, and complex matrix handling
  • Mentor research associates, establish SOPs, and build institutional knowledge within the bioanalytical function
Requirements
  • PhD in molecular biology, biochemistry, cell biology, or a related field or equivalent industry experience (5+ years)
  • 3+ years of hands-on experience in various quantitative bioanalytical assay platforms (e.g., RT-qPCR, ddPCR, ELISA, MSD, Olink, SOMAscan, NGS-based methods) in complex biological matrices (serum, plasma, tissue homogenates)
  • Strong working knowledge of bioanalytical method qualification/validation principles for PK/PD biomarker measurements, including familiarity with ICH M10 guidelines and fit-for-purpose frameworks
  • History of delivering results for bioanalytical projects -- you've discovered a PD biomarker or built an assay and solved all the problems along the way
  • Experience with primary cell culture and tissue-derived sample workflows
Nice to have
  • Track record of bioanalytical method transfer and CRO management for outsourced projects
  • Familiarity with preclinical drug development timelines and regulatory submissions (IND, TGA, CTD format)
  • Experience with mRNA-LNP biodistribution or nucleic acid-based PK assays
  • Experience developing products in emerging therapeutic modalities (gene therapy, nucleic acid therapies, cell therapy)
Benefits
NewLimit provides generous benefits so our team can remain focused on our mission:
  • Comprehensive Health, Dental, and Vision insurance
  • 401(k) plan with company match
  • Paid parental leave
  • Industry-leading PTO: 20 days per year plus holidays
  • On-site meals and snacks

Salary Range: $155,000 to $200,000. Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. NewLimit offers a competitive benefits package, which includes a 401k, healthcare coverage, and 20 days of PTO. Learn more at: https://www.newlimit.com/careers *This compensation and benefits information is based on Company's good faith estimate as of the date of publication and may be modified in the future.