Senior Analytical Development Reviewer

August Bioservices; Nashville (TN); On-site; USD 90,000 - 120,000; Full time

Job summary

August Bioservices, headquartered in Nashville, TN, seeks an experienced analytical professional to lead the preparation, review, and approval of analytical reports, methods, and validation documents. You will support development activities across drug substance and product programs, ensuring data integrity and regulatory alignment.

The role requires a Master’s or Bachelor’s with pharma experience and hands-on work with HPLC/UPLC, LC-MS, GC-MS, and other analytical techniques.

Qualifications

• Requires graduate degree with 2+ years pharma experience or a bachelor’s with 3–5 years in pharma.
• 3+ years reviewing cGMP analytical method documents.
• Experience in analytical development, reporting, or related pharma functions.
• Strong understanding of small-molecule analytics, validation and transfer.
• Proven 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 to ensure timely docs.
• Support method development, validation, qualification, transfer, lifecycle mgmt.
• Prepare and manage technical documents including validation reports.
• Coordinate reporting for drug substance/product stability programs.
• Participate in investigations of deviations, OOS/OOT events.
• Lead continuous improvement of analytical reporting processes and data integrity.

Skills

Analytical thinking

Scientific writing

Cross-functional collaboration

Project management

Regulatory compliance

Data interpretation

Microsoft Office

Education

Master's degree in a related field

Bachelor's degree in a related field

Tools

HPLC/UPLC

LC-MS

GC-MS

ICP-MS

Capillary electrophoresis

Particle size analysis

Wet chemistry

Job description

August Bioservices, headquartered in Nashville, TN, seeks an experienced analytical professional to lead the preparation, review, and approval of analytical reports, methods, and validation documents. You will support development activities across drug substance and product programs, ensuring data integrity and regulatory alignment.

The role requires a Master’s or Bachelor’s with pharma experience and hands-on work with HPLC/UPLC, LC-MS, GC-MS, and other analytical techniques.