... Director, Analytical Sciences will provide scientific leadership and strategic direction for ... Bioassay, Quality, Manufacturing, and Regulatory Affairs to ensure integrated CMC strategies.
Quick apply
... Director, Analytical Sciences will provide scientific leadership and strategic direction for ... Bioassay, Quality, Manufacturing, and Regulatory Affairs to ensure integrated CMC strategies.
Associate Director, Analytical Sciences (Tech Ops)
Durham, NC · On-site
$165K - $220K/yr
About the Position The Associate Director, Analytical Sciences will provide scientific leadership ... Bioassay, Quality, Manufacturing, and Regulatory Affairs to ensure integrated CMC strategies.
Quick apply
Associate Director, Analytical Sciences (Tech Ops)
Durham, NC · On-site
$165K - $220K/yr
About the Position The Associate Director, Analytical Sciences will provide scientific leadership ... Bioassay, Quality, Manufacturing, and Regulatory Affairs to ensure integrated CMC strategies.
Director Bioassay Scientist information
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?
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.
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?
| Aspect | Director Bioassay Scientist | Senior Bioassay Scientist |
|---|---|---|
| Credentials | Typically requires a PhD or Master’s in biology, immunology, or related field; extensive experience in bioassay development | Usually requires a Master’s or PhD; significant experience in bioassay techniques |
| Work Environment | Leads teams, manages projects, and collaborates with cross-functional departments | Performs hands-on bioassay work, data analysis, and method validation |
| Employer & Industry | Found in biotech, pharmaceutical, and contract research organizations | Commonly 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 are the most commonly searched types of Bioassay Scientist jobs in Raleigh, NC?
The most popular types of Bioassay Scientist jobs in Raleigh, NC are:
What are popular job titles related to Director Bioassay Scientist jobs in Raleigh, NC?
For Director Bioassay Scientist jobs in Raleigh, NC, the most frequently searched job titles are:
- Senior Scientist
- Senior Fermentation Scientist
- Senior Analytical Scientist
- Senior Associate Scientist
- Entry Level Protein Purification Scientist
- Freelance Protein Engineering Scientist
- Part Time Protein Purification Scientist
- Freelance Scientist Vaccine Development
- Full Time Scientist Enzymology
- Phd Scientist Mass Spectrometry
What job categories do people searching Director Bioassay Scientist jobs in Raleigh, NC look for?
The top searched job categories for Director Bioassay Scientist jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Director Bioassay Scientist jobs?
Cities near Raleigh, NC with the most Director Bioassay Scientist job openings:
Full-time
Posted 14 days ago
Job description
SUMMARY
- Clinical-stage biotech advancing antibody into Phase 2b
- Senior scientific leader for analytical strategy — control strategy, comparability, validation, characterization through BLA
- Direct ownership, no layers; drive the work with CDMOs and external labs
About the Position
The Associate Director, Analytical Sciences will provide scientific leadership and strategic direction for analytical sciences across the biologics development portfolio. Reporting to the Senior Director, Tech Ops, this individual will establish department-wide analytical strategies, drive late-stage analytical development, and provide technical leadership to ensure robust, phase-appropriate analytical control strategies and analytical methods. The Associate Director will also ensure phase-appropriate characterization of our products to ensure a growing state of knowledge leading all the way to a BLA filing. Working collaboratively with Analytical Project Leads and other functional leaders, the Associate Director will help integrate analytical activities across programs, strengthen technical capabilities, and prepare development programs for late-stage clinical development and eventual commercialization. This position serves as the senior scientific leader for Analytical Sciences and functions as a strategic partner to Analytical Project Leads and other functional experts. The role focuses on advancing analytical capabilities, enabling late-stage development, and ensuring scientific excellence across the portfolio while collaborating with program leaders responsible for day-to-day execution. This full-time, regular position will be located onsite in Durham, NC.
Summary of Key Responsibilities
Functional Leadership
- Establish and evolve the Analytical Sciences strategy to support the company's growing development portfolio.
- Develop best practices, scientific standards, and analytical governance across programs.
- Identify opportunities to strengthen departmental capabilities, technologies, and external partnerships.
- Mentor scientists and contribute to building a high-performing analytical organization.
Technical Leadership
- Provide scientific leadership for analytical lifecycle management, comparability strategies, method validation, specification development, reference standard strategy, and control strategy development.
- Guide analytical planning for late-stage clinical development, process validation, commercial readiness, and regulatory submissions.
- Lead scientific evaluation of complex analytical challenges and recommend strategic solutions.
Cross-Program Collaboration
- Partner with Analytical Project Leads to provide scientific consultation, establish department-wide analytical strategies, and promote consistency of analytical approaches across the development portfolio.
- Collaborate with Cell Line Development, Upstream and Downstream Process Development, Formulation Development, Pilot Plant, Bioassay, Quality, Manufacturing, and Regulatory Affairs to ensure integrated CMC strategies.
- Support portfolio planning by identifying cross-program opportunities, technical risks, and resource needs.
- Support Quality in updating SOPs and procedures to be phase appropriate
External Scientific Leadership
- Provide scientific oversight for external analytical laboratories and CROs.
- Lead technical interactions with external partners and support due diligence, technology transfers, and regulatory inspections.
- Evaluate emerging analytical technologies and recommend implementation where appropriate.
- Lead investigations as necessary for out-of-trend / out-of-specification results
Required Qualifications
We are looking for professionals with the following required skills to achieve our goals:
- Ph.D. in Chemical/Biochemical Engineering or related Biological Sciences with 6+ years of experience in the Pharmaceutical/Biotech analytical CMC industry, or B.S./M.S. in in Chemical/Biochemical Engineering or related Biological Sciences with 12 years of experience in the Pharmaceutical/Biotech industry analytical CMC industry
- Demonstrated experience advancing biologic products through IND and clinical development
- Experience leading multidisciplinary CMC teams in a matrix environment.
- Experience managing CDMOs and external development partners
- Strong understanding of CMC regulatory expectations for biologic products
- Excellent communication, leadership, and project management skills
Preferred Qualifications
- Experience supporting Phase 2/3 development, commercial readiness and BLA submissions
- Experience with addressing regulatory questions from worldwide health authorities
- Experience with technology transfer, comparability, process validation, and lifecycle management
- Experience supporting due diligence and strategic partnerships with CROs as well as providing oversight to these companies
- Experience working in a fast-paced biotechnology environment with multiple concurrent development programs