Senior Technology Transfer MS&T Engineer

August Bioservices, LLC; Nashville (TN); On-site; USD 110,000 - 150,000; Full time

Job summary

August Bioservices in Nashville seeks a Technology Transfer MS&T Engineer to drive aseptic process technology transfer, scale-up, and process optimization. You will collaborate with multiple departments to ensure robust transfer of sterile drug products and biologics.

The role requires deep aseptic process knowledge, DOE experience, and the ability to generate data-driven solutions for process improvements and regulatory readiness.

Qualifications

• Experience in pharmaceutical aseptic process implementation and GMP fundamentals.
• Experience leading technology transfer and scale-up activities.
• Ability to develop data-driven recommendations for process improvement.

Responsibilities

• Review transfer documents and provide technical analysis of the manufacturing process.
• Lead data evaluations during development and scale-up for optimization opportunities.
• Train teams on new processes and equipment; develop SOPs and work instructions.

Skills

Aseptic processing

Process transfer

DOE studies

Quality-by-Design

Education

B.S./M.S./Ph.D. in Pharmaceutical Sciences

Tools

Minitab

Microsoft Office

Job description

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.

Responsibilities

• 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 MasterControl, including change control (MOC), CAPA, issue reviews, and work orders.

Education

• 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, sterilize‑in‑place principles, product dosing technologies and GMP fundamentals in production environments.
• Experience developing technical recommendations in support of new process introductions.

Additional Skills

• Knowledge of high‑pressure homogenization, rotary evaporators, high shear homogenizers, microfluidizers, extrusion, lyophilization, PFS, vial filling operations, etc.
• Knowledge of pharmaceutical processing technologies such as mixers, transfer pumps, and temperature control devices.
• Knowledge of appropriate process requirements for sterile operations, including compounding, sterile filtration, aseptic formulation, sterile filling for vials, pre‑filled syringes and flexible IV bags.
• Proficiency with Minitab and Microsoft Office.

Physical Requirements

• Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
• Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and PPE.
• Ability to wear and operate a PAPR for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
• Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical‑resistant gloves, and additional protective equipment as required by operational and safety procedures.
• Regularly required to stand and walk for extended periods on hard warehouse and production flooring throughout the shift.
• Frequently required to bend, stoop, kneel, and reach in both upward and downward directions.
• Must be able to occasionally lift and/or move up to 50 lbs; frequently lift and/or move up to 40 lbs; and constantly reposition or transfer objects of negligible weight.
• Must be able to push and pull loaded carts, pallet jacks, and hand trucks across production and warehouse surfaces.
• Required to safely climb ladders to access materials stored at height.
• Must be able to operate powered industrial equipment including forklifts and electric pallet jacks, including the physical demands associated with vibration exposure and repetitive upper‑body movement.
• Required to work in varying temperature environments, including ambient, refrigerated, and frozen storage areas, using appropriate PPE.
• Must be able to wear and work in full cleanroom gowning (including gown, gloves, mask, hairnet, and shoe covers) for extended periods as required by the production area.
• Specific vision requirements include close vision, distance vision, peripheral vision, depth perception, and the ability to read small print on labels and batch documents.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.