Analytical Development Reviewer | Data & Reports Lead

August-Bioservices; Nashville (TN); On-site; USD 85,000 - 110,000; Full time

Job summary

August Bioservices, based in Nashville, is seeking an experienced analyst to lead the preparation and review of analytical reports and technical documentation. The role supports development and release activities across drug substance and product, ensuring traceability and regulatory alignment.

You will review data packages, collaborate with scientists, and drive improvements in reporting quality while maintaining rigorous cGMP standards in a fast-paced biotech environment.

Qualifications

• Master's or Bachelor's degree in a pharmaceutical science with relevant experience.
• 3+ years reviewing cGMP analytical method documents or related records.
• Experience with analytical development, reporting and regulatory alignment.
• Solid understanding of small-molecule analytical development and control strategies.
• Strong written communication and ability to present technical data clearly.

Responsibilities

• Lead preparation, review, and approval of analytical reports, data summaries, and validation documents.
• Review data packages supporting release testing and stability studies.
• Collaborate with scientists to ensure timely completion of analytical documentation.
• Support method development, validation, transfer, and lifecycle management.
• Prepare, review, and manage documents including methods, validations, and trend reports.
• Coordinate reporting for stability programs and ensure data integrity and compliance.
• Participate in investigations of deviations and regulatory events, documenting findings.
• Drive continuous improvement of reporting processes and data quality.

Skills

Analytical method development

Documentation review

cGMP compliance

Scientific writing

Project management

Education

Master's degree in Pharmaceutical Science

Bachelor's degree in Pharmaceutical Science

Tools

HPLC/UPLC

LC-MS

GC-MS

ICP-MS

Job description

August Bioservices, based in Nashville, is seeking an experienced analyst to lead the preparation and review of analytical reports and technical documentation. The role supports development and release activities across drug substance and product, ensuring traceability and regulatory alignment.

You will review data packages, collaborate with scientists, and drive improvements in reporting quality while maintaining rigorous cGMP standards in a fast-paced biotech environment.