Senior Technology Transfer MS&T Engineer

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) that provides a wide array of expert drug discovery, formulation, and manufacturing services to pharma and biotech companies of all sizes. Our work is instrumental in developing molecules that can become life-changing therapies.

To support our continued growth, we are investing in a new state-of-the-art facility adjacent to our current location. For those seeking dynamic opportunities, rewarding career paths, and a chance to make a difference in global health, come grow with August!

August Bioservices is seeking a Technology Transfer MS&T Engineer (Technical Services) reporting to the Sr. Director of Technical Operations. The candidate will serve as a Technical Services expert for aseptic process implementations and will be a core team member in customer‑facing collaborations. An extensive understanding of pharmaceutical sterile processing principles, process development, scale‑up approaches, and biopharmaceuticals is required. Experience with single‑use system technologies and compliant process segregation is preferred.

Technical knowledge of current equipment, process controls, support utilities, and sampling technologies is essential for the development, optimization, and technology transfer of small and large molecule fill/finish operations.

The incumbent is responsible for tasks associated with the technology transfer of sterile drug products and biologics, working with Formulation Development, Process Engineering, Analytical Development, Production, Quality and Regulatory to identify product and process criticalities and find data‑driven solutions.

• Review technology transfer documents such as product development reports, batch manufacturing, and packaging records to provide technical analysis of the overall process.
• Identify gaps in capabilities needed to support new product/process introductions and recommend solutions to close these gaps.
• Lead evaluations of collected data during development and scale‑up activities and recommend opportunities for process optimization.
• Lead training and familiarization efforts for new processes and equipment, including development of operation SOPs and work instructions.
• Lead and/or support the execution of toxicological, clinical, scale‑up, registration, commercial, and process performance qualification with the production team.
• Lead the evaluation and selection of new equipment in support of fill/finish production operations in collaboration with clients and internal stakeholders.
• Work with R&D, Facilities and Validation teams on process implementation to develop a detailed plan based on the approved scope of work.
• Participate in multidisciplinary project teams through the complete product transfer to support ongoing client projects on time.
• Conduct phase‑specific studies based on design of experiments (DOE) as needed, for formulation optimization and process confirmation.
• Incorporate a Quality‑By‑Design (QbD) approach in the product development program to improve drug formulation and manufacturing processes.
• Conduct investigations and corrective action analysis and support.
• Write comprehensive technical reports, business evaluations, and process descriptions with or without supervision.
• Write documents including master batch records, protocols, SOPs, work instructions, and other necessary technical documents.
• Troubleshoot and resolve simple to moderately complex technical issues, diagnosing problems and identifying short‑ and long‑term solutions.
• Work with cross‑functional teams to identify opportunities for enhancements and champion projects that improve overall site function.
• Proficient in quality system software such as Master Control, including change control (MOC), CAPA, issue reviews, and work orders.

• B.S., M.S., or Ph.D. in Pharmaceutical Sciences (or equivalent).
• 5+ years of equivalent experience.
• Experience in pharmaceutical aseptic process implementation, including new equipment, sterile filtration,…