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August Bioservices is a privately-owned, high-growth Contract Development Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. The company provides drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, and is currently undergoing significant expansion with a new state-of-the-art facility under construction.
The Technical Reviewer, Analytical Development role is a senior individual contributor position responsible for leading the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, and analytical methods. Key responsibilities include reviewing analytical data packages supporting release testing and stability studies (including raw chromatographic data and Empower-generated reports), collaborating with scientists and cross-functional teams to ensure accurate and timely completion of analytical documentation, and supporting analytical method development, validation, qualification, and transfer activities across development and commercial programs.
The role also involves preparing and managing technical documents such as analytical methods, validation protocols and reports, and specifications; coordinating analytical reporting for drug substance and drug product stability programs; participating in investigations related to deviations, out-of-specification (OOS), out-of-trend (OOT), and other laboratory events; and leading continuous improvement initiatives to enhance analytical reporting processes, data integrity, and operational efficiency.
This is a hands-on technical role requiring deep expertise in pharmaceutical analytical development and regulatory compliance. The position requires flexibility to work shifts or weekends as needed to meet timelines.
REQUIREMENTS:
- Master's degree with 2+ years of pharmaceutical experience, OR Bachelor's degree with 3-5 years of pharmaceutical experience
- 3+ years of experience reviewing cGMP analytical method documents
- Experience in analytical development, analytical reporting, or related pharmaceutical development functions
- Strong understanding of small-molecule analytical development, method validation and transfer, stability testing, specifications, and analytical control strategies
- Demonstrated experience preparing, reviewing, and approving technical documentation including analytical methods, protocols, and reports
- Working knowledge of analytical techniques: HPLC/UPLC, LC-MS, GC-MS, ICP-MS, wet chemistry, particle size analysis, capillary electrophoresis, and other pharmaceutical characterization techniques
- Familiarity with ICH, FDA, EMA, and other global regulatory requirements applicable to analytical development
- Strong scientific writing, data interpretation, problem-solving, and project management capabilities
- Excellent written and verbal communication skills with ability to convey complex technical information to diverse audiences
- Proficiency in Microsoft Office applications
- Proven ability to collaborate effectively within cross-functional, matrixed organizations
- Highly organized with ability to manage multiple priorities and deadlines in a fast-paced biotech environment
