Senior Scientist: Analytical Method Transfer & QC

Actalent; Wilson (NC); On-site; USD 69,000 - 76,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability Insurance

HSA

Transportation benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent in Wilson, NC is seeking a Senior Scientist to lead analytical method transfer, verification, and covalidation for sterile injectable products. The role centers on supporting new product launches, release testing, and stability programs within a GMP QC setting.

The onsite senior scientist will work closely with QC, Technical Transfer, and Production, mentoring staff and driving continuous improvement while ensuring data integrity and regulatory compliance across analyses (HPLC, GC,

Qualifications

• Minimum 8 years in pharmaceutical GMP environment.
• Strong analytical chemistry skills in QC or development labs.
• Hands-on experience with method transfer, verification, and covalidation.
• Proficiency with HPLC, GC, FTIR, UV-Vis, Karl Fischer.
• Experience with stability and release testing for pharma products.
• Ability to write and execute method transfer/validation protocols and reports.
• Strong data interpretation and technical writing abilities.
• Regulatory knowledge related to analytical methods and release testing.

Responsibilities

• Coordinate and execute method transfers, verifications, and covalidations of analytical methods.
• Plan, execute, and document verification protocols for USP methods.
• Review data and verification reports for accuracy and regulatory alignment.
• Liaise between QC, I&D, Production to implement new testing procedures.
• Act as SME for critical analytical tests supporting new product launches.
• Lead QC conformance reviews of release and stability data.
• Troubleshoot analytical methods and instrumentation issues in QC labs.
• Prepare documentation for regulatory submissions as needed.
• Review and update SOPs, test methods, and specifications.
• Train laboratory staff on new techniques and instruments.
• Execute complex analyses for organic/inorganic compounds to define properties.

Skills

GMP experience

Analytical chemistry

Method transfer

Data interpretation

Troubleshooting instrumentation

Technical writing

Regulatory knowledge

HPLC

GC

FTIR

UV-Vis

Karl Fischer

Tools

HPLC

GC

FTIR

UV-Vis

Karl Fischer

Coagulation analyzers

Job description

Actalent in Wilson, NC is seeking a Senior Scientist to lead analytical method transfer, verification, and covalidation for sterile injectable products. The role centers on supporting new product launches, release testing, and stability programs within a GMP QC setting.

The onsite senior scientist will work closely with QC, Technical Transfer, and Production, mentoring staff and driving continuous improvement while ensuring data integrity and regulatory compliance across analyses (HPLC, GC,