Technical Reviewer, Analytical Development

About the role

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment. We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

Responsibilities

• Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, analytical methods, and other technical documentation.
• Review analytical data packages supporting release testing and stability studies, including raw chromatographic data and Empower-generated reports.
• Collaborate closely with Scientists and cross-functional teams to ensure analytical documentation and reports are completed accurately and within established timelines.
• Support analytical method development, validation, qualification, transfer, and lifecycle management activities across development and commercial programs.
• Prepare, review, and manage technical documents, including analytical methods, validation protocols and reports, specifications, and analytical trend reports.
• Coordinate analytical reporting activities for drug substance and drug product stability programs, ensuring analytical data are accurately documented, assessed, and communicated.
• Participate in investigations associated with deviations, OOS, OOT, and other laboratory events, ensuring appropriate documentation and compliance with quality and regulatory requirements.
• Lead continuous improvement initiatives designed to enhance analytical reporting processes, data integrity, document quality, and operational efficiency.

Qualifications

• Master's degree with 2+ years of pharmaceutical experience or a Bachelor's degree with 3-5 years of pharmaceutical experience.
• Must have 3 or more years of reviewing cGMP analytical method documents.
• Experience in analytical development, analytical reporting, or related pharmaceutical development functions.
• Strong understanding