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Manager Bioassay Scientist Jobs (NOW HIRING)

Iff

Scientist II

Wilmington, DE · On-site

Develop, qualify, validate, and manage lifecycle of analytical and bioassay methods used for ... Focus on innovation, scientific rigor, and continuous improvement. * Inclusive, collaborative, and ...

Moderna Therapeutics

Sr. Automation Engineer

Norwood, MA

$117K - $154K/yr

Collaborate with scientists to translate cell-based bioassays and sample preparation workflows into ... Change control and lifecycle management * Documentation aligned with regulatory expectations

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How much do manager bioassay scientist jobs pay per year?

As of Aug 15, 2026, the average yearly pay for manager bioassay scientist in the United States is $61,351.00, according to ZipRecruiter salary data. Most workers in this role earn between $44,000.00 and $69,000.00 per year, depending on experience, location, and employer.

What is a manager bioassay scientist?

A Manager Bioassay Scientist is a professional who oversees the development, validation, and implementation of bioassays—laboratory tests that measure the effects of biological substances. This role involves managing teams, ensuring that assays comply with regulatory standards, and supporting the quality control of pharmaceuticals or biologics. They collaborate with cross-functional teams, analyze assay data, and contribute to the development of new testing methods. The position requires strong leadership, scientific expertise, and knowledge of regulatory guidelines.

What are the key skills and qualifications needed to thrive as a manager bioassay scientist?

To thrive as a Manager Bioassay Scientist, you need a strong background in biochemistry, molecular biology, or related fields, often with an advanced degree and relevant laboratory experience. Proficiency with bioassay platforms, data analysis software, and familiarity with regulatory standards such as GMP or GLP is typically required. Leadership, problem-solving, and effective communication are essential soft skills for managing teams and coordinating cross-functional projects. These competencies ensure the development of accurate assays, regulatory compliance, and the effective oversight of laboratory operations.

What is the difference between Manager Bioassay Scientist vs Bioassay Scientist?

AspectManager Bioassay ScientistBioassay Scientist
CredentialsBachelor's or Master's in Life Sciences, often with management experienceBachelor's or Master's in Life Sciences, specialized in bioassay techniques
Work EnvironmentLeads teams, oversees projects, manages lab operationsConducts experiments, performs bioassays, analyzes data
Employer & Industry UsagePharmaceutical, biotech companies, CROsPharmaceutical, biotech, research labs

The main difference is that the Manager Bioassay Scientist oversees bioassay teams and manages projects, while the Bioassay Scientist focuses on performing experiments and analyzing data. The manager role involves leadership and coordination, whereas the scientist role is more technical and hands-on.

How does a manager bioassay scientist typically collaborate with cross-functional teams during the development of new biologics?

A Manager Bioassay Scientist often works closely with cross-functional teams such as analytical development, quality control, regulatory affairs, and process development. This collaboration ensures that bioassay methods are robust, compliant with regulatory standards, and aligned with project timelines. The role frequently involves coordinating assay transfer activities, troubleshooting assay performance, and communicating complex scientific data to both technical and non-technical stakeholders, making strong teamwork and communication skills essential.

What cities are hiring for Manager Bioassay Scientist jobs?

Cities with the most Manager Bioassay Scientist job openings:

What are the most commonly searched types of Bioassay Scientist jobs?

The most popular types of Bioassay Scientist jobs are:

What states have the most Manager Bioassay Scientist jobs?

States with the most job openings for Manager Bioassay Scientist jobs include:

Manager Bioassay Scientist jobs near you

Principal Scientist, CMC Analytical Development - Commercial Products

Denali Therapeutics

South San Francisco, CA • On-site

Full-time

Medical, Retirement

Posted 13 days ago

Job description

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Denali recently achieved a major company milestone with the commercial launch of its first product, AVLAYAH, approved through the FDA's accelerated approval pathway. As the product transitions into routine commercial production and Denali pursues marketing applications in additional countries, we are seeking a Principal Scientist to join our Large Molecule Analytical Development Team to serve as a Commercial Analytical Lifecycle Lead. This individual will provide technical analytical expertise for commercial manufacturing and QC activities; lead analytical method transfers to support in-country testing; and lead international registration of the established commercial process with additional global health authorities. The Commercial Analytical Lifecycle Lead is expected to partner closely with peer Late Stage Analytical Development and Bioassay Development Leads responsible for driving successful analytical transfer & registration of a second-source manufacturing and QC site. The scope of the role is expected to expand as additional programs advance to commercialization.
Key Responsibilities
Commercial Manufacturing & QC Analytical Support
  • Provide technical analytical review and approval of CMO manufacturing documents for routine commercial production
  • Perform technical assessment and approval of change controls impacting analytical methods, specifications, reference standards, and QC testing processes in close collaboration with Late Stage Analytical Development, Bioassay Development, and Drug Product Development Leads.
  • Serve as analytical subject matter expert (SME) for manufacturing deviations and QC laboratory investigations (OOS/OOT, atypical results), including root cause assessment and CAPA evaluation
  • Monitor ongoing method and process performance trends at the CMO to proactively identify risks to commercial supply or product quality
  • Provide technical review and approval of APQR in collaboration with Quality.
  • Ensure continuous compliance of methods and control strategies with current industry guidelines (ICH, Pharmacopeia, FDA/EMA guidance) and best practices (BioPhorum or other consortia white papers).

Analytical Method Transfer - In-Country Testing & International Registration
  • Own and oversee analytical method transfer activities to support in-country/regional testing requirements as new marketing applications are submitted and approved internationally
  • Develop and execute method transfer risk assessments and protocols, acceptance criteria, and transfer reports in collaboration with receiving testing laboratories
  • Coordinate with Regulatory Affairs, CMC, and QA to align method transfer timelines with global submission and launch schedules
  • Ensure consistency methods/specifications across testing sites and support harmonization where appropriate

Global Health Authority Support
  • Provide analytical/CMC technical expertise in response to health authority questions from regulatory agencies as part of international expansion.
  • Draft and review technical responses to information requests related to analytical methods, specifications, validation, and control strategy

Cross-Functional Collaboration
  • Partner closely with the peer analytical leads responsible for method/process transfer and scale-up at the second-source CMO to ensure consistent analytical strategy across manufacturing sites and international QC labs.
  • Collaborate with CMC, Quality, Regulatory Affairs, Supply Chain, and CMO counterparts to support uninterrupted commercial supply
  • Represent Analytical Sciences on cross-functional teams for commercial lifecycle management activities

Minimum Qualifications
  • BS/MS/PhD in Chemistry, Chemical Engineering, Analytical Chemistry, Biochemistry, or related scientific discipline (PhD with 10+ years or MS/BS with 14+ years of relevant industry experience)
  • Demonstrated track record as a recognized analytical/technical subject matter expert, able to operate with a high degree of independence and exercise sound scientific judgment on complex, ambiguous problems with limited managerial oversight
  • Significant hands-on experience with biologics analytical methods (e.g., potency/enzymatic activity assays, ELISA, HPLC/UPLC, capillary electrophoresis, mass spectrometry, glycan analysis) relevant to protein/enzyme-Fc fusion products
  • Direct experience supporting commercial (post-approval) biologics manufacturing, including batch record review, change control, and QC deviation/investigation support (e.g., OOS/OOT root cause analysis and CAPA frameworks)
  • Experience with analytical method transfer, method validation/qualification (ICH Q2), and technical transfer documentation
  • Working knowledge of global regulatory requirements and experience supporting health authority interactions or submissions (FDA, EMA, and other international agencies)
  • Experience working with and providing oversight of external CMOs/contract testing laboratories
  • Strong written and verbal communication skills, with ability to author clear, defensible technical and regulatory documentation
  • Ability to travel domestically and internationally as needed

Preferred Qualifications
  • Experience with enzyme replacement therapies, Fc-fusion proteins, or rare disease biologics
  • Experience with products launched under accelerated approval or other expedited regulatory pathways
  • Familiarity with ex-US and ex-EMA health authority expectations regarding analytical and QC testing requirements
  • Experience supporting pre-approval inspections (PAI) or health authority audits
  • Prior experience managing multiple external manufacturing/testing sites simultaneously

What Success Looks Like in This Role
  • Reliable, timely analytical technical review supporting uninterrupted commercial batch disposition
  • Successful, on-time method transfers enabling in-country testing for new international market launches
  • Clear, scientifically rigorous responses to global health authority questions that support timely application approvals
  • Strong, collaborative working relationship with the CMO and with the peer analytical leads overseeing analytical and process transfer/scale-up at second source manufacturing & QC site

Salary Range: $159,000.00 to $207,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

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