Senior Analytical Development Reviewer (cGMP)

August Bioservices LLC; Nashville, Northern (TN, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

August Bioservices in Nashville, TN is seeking an experienced Analytical Documentation Specialist to lead the preparation, review, and approval of analytical reports, methods, and data. You will collaborate with Scientists and cross-functional teams to ensure timely, compliant documentation across development and commercial programs.

Responsibilities include supporting method development and validation, reviewing data packages for release testing and stability studies, and driving continuous

Qualifications

• Master's degree with 2+ years of pharma experience or Bachelor's with 3-5 years.
• 3+ years reviewing cGMP analytical method documents.
• Experience in analytical development and reporting.
• Knowledge of small-molecule analytical development and validation.
• Strong ability to prepare, review, and approve technical docs.

Responsibilities

• Lead preparation, review, and approval of analytical reports and methods.
• Review data packages for release testing and stability studies.
• Collaborate with Scientists and cross-functional teams on documentation timelines.
• Support method development, validation, transfer, and lifecycle activities.
• Coordinate reporting for stability programs and data communication.
• Participate in investigations of deviations and lab events.
• Lead continuous improvement of reporting processes and data integrity.

Skills

Scientific writing

Data interpretation

Project management

Cross-functional collaboration

Communication skills

Quality/regulatory awareness

Education

Master's degree (pharma)

Bachelor's degree (pharma)

Tools

HPLC/UPLC

LC-MS

GC-MS

ICP-MS

Capillary electrophoresis

Analytical method validation

Job description

August Bioservices in Nashville, TN is seeking an experienced Analytical Documentation Specialist to lead the preparation, review, and approval of analytical reports, methods, and data. You will collaborate with Scientists and cross-functional teams to ensure timely, compliant documentation across development and commercial programs.

Responsibilities include supporting method development and validation, reviewing data packages for release testing and stability studies, and driving continuous