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Director Bioassay Scientist Jobs (NOW HIRING)

CooperCompanies

Embryologist Scientist

Sugar Land, TX · On-site

... bioassay systems used to assess the safety, efficacy, and performance of assisted reproductive ... The position has direct influence on biological risk assessment, regulatory readiness, product ...

NorthEastern

Associate Research Scientist

Boston, MA · On-site

$67K - $95K/yr

Direct and oversee bioassay development, screening, and hit validation efforts. * Manage compound ... Provide scientific leadership and mentorship for junior researchers and technical staff. * Ensure ...

Iff

Scientist II

Wilmington, DE

Apply advanced bioanalytical and bioassay expertise to support global manufacturing, product ... Ability to manage projects and influence outcomes without direct authority. * Experience working in ...

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Director Bioassay Scientist information

What are some typical challenges a Director Bioassay Scientist faces when leading cross-functional teams in assay development projects?

A Director Bioassay Scientist often navigates challenges such as aligning diverse scientific perspectives, managing tight project timelines, and ensuring clear communication between departments like research, regulatory, and quality assurance. Balancing innovation with regulatory compliance is also critical, as is mentoring team members while driving projects forward. Success in this role requires strong leadership, adaptability, and the ability to foster collaboration across multidisciplinary teams to achieve shared goals.

What is the difference between Director Bioassay Scientist vs Senior Bioassay Scientist?

AspectDirector Bioassay ScientistSenior Bioassay Scientist
CredentialsTypically requires a PhD or Master’s in biology, immunology, or related field; extensive experience in bioassay developmentUsually requires a Master’s or PhD; significant experience in bioassay techniques
Work EnvironmentLeads teams, manages projects, and collaborates with cross-functional departmentsPerforms hands-on bioassay work, data analysis, and method validation
Employer & IndustryFound in biotech, pharmaceutical, and contract research organizationsCommonly employed in similar settings, often within R&D departments

The main difference is that the Director Bioassay Scientist oversees teams and projects, focusing on strategic leadership, while the Senior Bioassay Scientist primarily conducts technical work and method development. Both roles require advanced credentials and industry experience, but the director position involves more managerial responsibilities.

What does a Director Bioassay Scientist do?

A Director Bioassay Scientist leads the development, validation, and implementation of bioassays to assess the potency, safety, and efficacy of biological products in pharmaceutical or biotechnology companies. This role includes overseeing laboratory teams, ensuring regulatory compliance, and collaborating with other departments such as quality assurance, regulatory affairs, and process development. The director is responsible for strategic planning, resource management, and staying current with advancements in assay technologies. They also play a key role in interpreting bioassay data and supporting submissions to regulatory agencies.

What are the key skills and qualifications needed to thrive as a Director Bioassay Scientist, and why are they important?

To thrive as a Director Bioassay Scientist, you need an advanced degree (PhD or equivalent) in biology, biochemistry, or a related field, along with extensive experience in assay development and validation. Expertise in technologies such as ELISA, cell-based assays, flow cytometry, and regulatory compliance systems like GLP or GMP is typically required. Strong leadership, project management, and cross-functional communication skills help drive team success and ensure alignment with organizational goals. These competencies are crucial for ensuring scientific rigor, regulatory compliance, and successful delivery of bioanalytical programs in a dynamic biotech environment.
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Director Bioassay Scientist jobs near you
Infographic showing various Director Bioassay Scientist job openings in the United States as of July 2026, with employment types broken down into 2% Locum Tenens, 2% Full Time, 86% Temporary, 6% Nights, and 4% Summer. Highlights an 1% Physical, and 99% Hybrid job distribution.
Scientist/Senior Scientist - Cell Bioassay/Potency

Scientist/Senior Scientist - Cell Bioassay/Potency

Frontage Laboratories

Exton, PA • On-site

$88K - $120K/yr

Full-time

Medical, Dental, Life, Retirement

Posted 17 days ago

Job description

Scientist/Senior Scientist - Cell Bioassay/Potency

Title: Scientist/Sr. Scientist, Cell Bioassay/Potency

Location: Exton, PA

Reports to: Sr Director BGC Therapy Operations

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.


Position/Job Summary:

The Scientist/ Sr. Scientist will be a leading member in the Analytical Technologies group responsible for bioassay development, validation, transfer, and execution at Gritstone Bio. The bioassays include cell-based potency assay, ELISA, PCR-based assays, and virus infectivity assays, etc., that are used to support product characterization, release, stability study in GMP setting as well as other research projects for process, formulation, and manufacturing development. This position will contribute to the strategy of selecting and implementing bioassays to ensure our products are comprehensively characterized and under superb quality control. With dedication to troubleshooting and optimizing assays on bench, this position may lead a small group to achieve department goals. Excellent training and background in biological sciences, such as cell biology, molecular biology, biochemistry, immunology, virology, etc., is required.


Roles & Responsibilities:

  • Develop and apply molecular biological methods, immunoassays, and other state of the art analytical technologies to analyze and characterize cell and gene products, biotherapeutic proteins, their conjugates, and variants.
  • Independently select, develop, validate, and transfer biological assays including cell-based potency assays, ELIZA, qPCR-based assays, virus infectivity assays, etc.
  • Perform method development, validation, tech transfer, product characterization, impurity profiling, routine, and stability testing across varieties of biological products.
  • Prepare project proposals, protocols, reports, Certificate of Analysis, investigation reports, and generate cGMP documents.
  • Prepare and review notebooks in compliance with Frontage CMC SOPs.
  • Maintain qualification and compliance of instruments and conduct technical and instrumental troubleshooting.
  • Manage projects from initiation to completion and ensure the projects are on time and meeting pre-established quality standards.
  • Author method SOPs, development reports, qualification/validation reports to support method transfer to GMP QC
  • Perform analytical tests to support method development, DS/DP characterization, PD studies, lot release and stability testing of drug substance and drug products.
  • Development and optimization of analytical methods, in accordance with client requirements and associated protocol and procedures

Education, Experience & Skills Required:

Educational/Training Requirement:

  • PhD, MS or BS in Biological Science, Biochemical Engineering, or related discipline.


Experience:

  • PhD in Biological Science, Biochemical Engineering, or related discipline with 0-2 years’ relevant industrial GMP testing or analytical development experience for biologics or cell and gene therapy products, or
  • MS with 2-4 years’ GMP testing or analytical development experience for biologics or cell and gene therapy products, or
  • BS with 3-5 years’ GMP testing or analytical development experience for biologics or cell and gene therapy products.
  • Excellent organization and planning skills.
  • Experience in virus-vector based biotechnology or virology in general is preferred but not required.
  • Excellent communication skills, with the ability to work with individuals in wide ranging teams at all levels and the ability to lead and influence.

Salary and Benefits:

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.