ZipRecruiter

Log In

1

Associate Scientist Analytical Development Jobs in Raleigh, NC

Novartis

Scientist - Upstream Cell Culture

Durham, NC · On-site

$93K - $174K/yr

The Expert, Science & Technology - Upstream/Cell Culture, is responsible for cell & gene therapy ... Tracks records of collaborative relations with groups such as research and development, analytical ...

MedPharm Ltd

Scientist III, Analytical R/D

Durham, NC · On-site

$80 - $110/hr

Position Summary The Scientist III/ Sr. Scientist is responsible for developing and validating ... Develop and validate analytical methods to support formulation drug development under minimal ...

New

MedPharm

Scientist III, Analytical R/D

Durham, NC · On-site

Position Summary The Scientist III/ Sr. Scientist is responsible for developing and validating analytical methods to support drug formulation development in a GMP-compliant laboratory. This role ...

MedPharm

Scientist III, Analytical R/D

Durham, NC · On-site

Position Summary The Scientist III/ Sr. Scientist is responsible for developing and validating analytical methods to support drug formulation development in a GMP-compliant laboratory. This role ...

AskBio

Sr. Scientist, DNA Development

Durham, NC · On-site

... reports to the Process Development Associate Director/Director. Job Responsibilities ... Lead investigations and troubleshooting of DNA purification and analytical characterization as ...

AskBio

Sr. Scientist, DNA Development

Durham, NC · On-site

... reports to the Process Development Associate Director/Director. Job Responsibilities ... Lead investigations and troubleshooting of DNA purification and analytical characterization as ...

previous page

Showing results 41-60

All JobsAssociate Scientist Analytical Development JobsAssociate Scientist Analytical Development Jobs in Raleigh, NC

Associate Scientist Analytical Development information

See Raleigh, NC salary details

$18

$34

$55

How much do associate scientist analytical development jobs pay per hour?

As of Sep 4, 2026, the average hourly pay for associate scientist analytical development in Raleigh, NC is $34.92, according to ZipRecruiter salary data. Most workers in this role earn between $27.12 and $39.71 per hour, depending on experience, location, and employer.

What does an associate scientist analytical development do?

An Associate Scientist in Analytical Development is responsible for designing, conducting, and analyzing experiments to develop and validate analytical methods used in the testing of pharmaceutical products. They work closely with cross-functional teams to ensure the quality and consistency of drug formulations by using various laboratory techniques such as chromatography, spectroscopy, and wet chemistry. Their role is critical in supporting drug development, regulatory submissions, and ensuring products meet industry standards.

What are some common challenges an associate scientist analytical development might face when working on new drug formulations?

Associate Scientists in Analytical Development frequently encounter challenges such as developing robust analytical methods for complex or novel drug formulations and ensuring these methods meet regulatory standards. Balancing tight project timelines with the need to thoroughly validate methods can also be demanding. Additionally, they often need to troubleshoot unexpected results and collaborate closely with cross-functional teams—including formulation scientists and quality assurance—to resolve technical issues and deliver reliable data. These challenges require strong problem-solving skills and adaptability.

What are the key skills and qualifications needed to thrive as an associate scientist analytical development, and why are they important?

To thrive as an Associate Scientist Analytical Development, you need a solid background in chemistry, biochemistry, or a related field, often supported by a bachelor’s or master’s degree. Familiarity with analytical techniques like HPLC, GC, mass spectrometry, and relevant laboratory information management systems (LIMS) is typically required. Strong problem-solving skills, attention to detail, and effective teamwork are important soft skills for this role. These competencies ensure accurate data generation, regulatory compliance, and successful collaboration in the development of pharmaceutical products.

What is the difference between Associate Scientist Analytical Development vs Associate Scientist Quality Control?

AspectAssociate Scientist Analytical DevelopmentAssociate Scientist Quality Control
Required CredentialsBachelor's or Master's in Chemistry, Biology, or related field; relevant laboratory experienceBachelor's or Master's in Chemistry, Biology, or related field; laboratory experience often focused on testing
Work EnvironmentResearch and development labs, method development, process optimizationQuality control labs, testing, sample analysis, compliance with regulations
Employer & Industry UsagePharmaceutical, biotech companies, focus on method developmentPharmaceutical, biotech companies, focus on product testing and quality assurance

Associate Scientist Analytical Development primarily focuses on developing and optimizing analytical methods for new or existing products, while Associate Scientist Quality Control concentrates on testing and ensuring the quality of products before release. Both roles require similar educational backgrounds but differ in daily tasks and focus areas within the industry.

What are popular job titles related to Associate Scientist Analytical Development jobs in Raleigh, NC?

For Associate Scientist Analytical Development jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Associate Scientist Analytical Development jobs in Raleigh, NC look for?

The top searched job categories for Associate Scientist Analytical Development jobs in Raleigh, NC are:

What cities near Raleigh, NC are hiring for Associate Scientist Analytical Development jobs?

Cities near Raleigh, NC with the most Associate Scientist Analytical Development job openings:

Associate Scientist Analytical Development jobs near you
Infographic showing various Associate Scientist Analytical Development job openings in Raleigh, NC as of August 2026, with employment types broken down into 1% As Needed, 82% Full Time, 15% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $72,637 per year, or $34.9 per hour.

Associate Director or Director, CMC Regulatory Affairs

Atsena

Durham, NC • On-site

$180 - $260/hr

Other

Re-posted 20 days ago

Job description

Position Summary

The Associate Director / Director, CMC Regulatory Affairs will lead global CMC regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This role is responsible for developing CMC regulatory strategies across product development stages, supporting regulatory submissions, and serving as the regulatory liaison to internal CMC teams and external contract manufacturing organizations.

The individual will work cross-functionally with process development, analytical development, manufacturing, quality, and program leadership to ensure that CMC development plans meet regulatory expectations for gene therapy products. The role will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.

Key Responsibilities CMC Regulatory Strategy
  • Develop and implement global CMC regulatory strategies for gene therapy programs from early development through clinical stages and commercialization.
  • Provide regulatory guidance on viral vector manufacturing, process development, analytical characterization, and product comparability.
  • Assess regulatory risks related to manufacturing changes and propose mitigation strategies.
Regulatory Submissions
  • Lead preparation and review of CMC sections of global regulatory submissions, including: INDs and IND amendments, CTAs and IMPDs, BLA/MAA submissions and supplements, annual reports and regulatory updates
  • Ensure submissions meet regulatory expectations for gene therapy products.
Health Authority Interactions
  • Prepare CMC regulatory briefing documents and support agency meetings.
  • Serve as the subject matter expert for CMC topics during interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to regulatory agency questions related to CMC.
Cross-Functional Collaboration
  • Partner closely with internal teams including: Process Development, Analytical Development, Manufacturing, Quality
  • Serve as the CMC regulatory representative on cross-functional program teams.
  • Provide regulatory guidance for manufacturing changes, comparability strategies, and lifecycle management.
Regulatory Intelligence & Compliance
  • Monitor evolving regulatory guidance related to gene therapy and advanced biologics.
  • Interpret regulatory requirements and communicate implications to internal teams.
  • Support development of internal regulatory policies and processes.
Qualifications Education
  • PhD or MS in biochemistry, molecular biology, chemical engineering, pharmaceutical sciences, or related field.
Preferred Qualifications
  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience supporting late-stage development or BLA/MAA submissions.
  • Familiarity with global regulatory frameworks for advanced therapy medicinal products (ATMPs).
  • Prior experience participating in regulatory meetings.
Associate Director Experience
  • 7–10 years of experience in regulatory affairs and CMC.
  • Experience contributing to CMC sections of IND/CTA submissions.
Director Experience
  • 10–15+ years of experience in regulatory affairs with leadership responsibility for CMC regulatory strategy.
  • Demonstrated experience leading CMC regulatory submissions and health authority interactions.
Knowledge & Skills
  • Strong knowledge of global CMC regulatory requirements for biologics and gene therapies.
  • Understanding of viral vector manufacturing processes.
  • Experience with analytical characterization, comparability, and manufacturing changes.
  • Excellent regulatory writing and communication skills.
  • Ability to work effectively in a fast-paced startup environment.
Key Competencies
  • Strategic thinking and problem solving
  • Strong scientific and regulatory expertise
  • Cross-functional leadership
  • Excellent communication and collaboration skills
  • Ability to manage multiple programs and timelines
#J-18808-Ljbffr

Apply