Senior Technology Transfer MS&T Engineer

Augustbioservices; Nashville (TN); On-site; USD 90,000 - 140,000; Full time

Job summary

August Bioservices seeks a Technology Transfer MS&T Engineer (Technical Services) to support aseptic process implementations and customer‑facing collaborations. Role requires deep pharma sterile processing knowledge and strong data analysis capabilities.

Responsibilities include leading scale‑up evaluations, preparing SOPs and technical reports, and coordinating with R&D, Facilities, and Validation to ensure timely project delivery. Career growth in a dynamic team is available.

Qualifications

• Advanced degree in pharmaceutical sciences with 5+ years' related experience.
• Experience in aseptic process implementation and GMP principles.
• Proficiency with quality systems and document control software.

Responsibilities

• Review tech transfer documents to provide technical analysis.
• Lead data evaluations during development and scale‑up.
• Develop SOPs and work instructions for new processes.
• Collaborate with R&D, Facilities and Validation to plan implementation.
• Support process performance qualification with the production team.

Skills

Pharma process know‑how

Quality by Design

Cross‑functional collaboration

Troubleshooting

Documentation

Education

B.S., M.S. or Ph.D. in Pharmaceutical Sciences

Tools

Master Control

MOC

CAPA

Minitab

Microsoft Office

Job description

Job Overview

August Bioservices is seeking a Technology Transfer MS&T Engineer (Technical Services) reporting to the Sr. Director of Technical Operations. The role focuses on aseptic process implementations and serves as a core team member for customer‑facing collaborations. Candidates should have an extensive understanding of pharmaceutical sterile processing principles, process development and scale‑up approaches. Experience with biologics and single‑use system technologies is preferred.

Responsibilities

• Review technology transfer documents such as product development reports, batch manufacturing and packaging records to provide technical analysis.
• Identify gaps in capabilities needed to support new product/process introductions and recommend solutions.
• 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.
• Support execution of toxicological, clinical, scale‑up, exhibit/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 stakeholders.
• Work with R&D, Facilities and Validation teams to develop a detailed implementation plan based on the approved scope of work.
• Participate in multidisciplinary project teams through the complete product transfer and support ongoing client projects on time.
• Conduct phase‑specific studies based on design of experiments for formulation optimization and process confirmation.
• Apply a Quality‑by‑Design approach to improve drug formulation and manufacturing processes.
• Investigate and support corrective action analysis.
• Write comprehensive technical reports and business evaluations with or without supervision.
• Write technical documents including master batch records, protocols, reports, SOPs, work instructions, and other necessary documents.
• Troubleshoot and resolve technical issues, diagnosing problems and identifying short‑ and long‑term solutions.
• Work with cross‑functional team leads to identify enhancements and champion projects that improve site function.
• Proficient in quality system software such as Master Control, MOC, CAPA, issue reviews, work orders, collaboration, and approval of documents.

Qualifications

• 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, and GMP fundamentals.
• Experience developing technical recommendations for new process introductions.
• 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, temperature control devices.
• Knowledge of sterile operations requirements for compounding, sterile filtration, aseptic formulation, sterile filling of vials, pre‑filled syringes and flexible IV bags.
• Software skills in Minitab, Microsoft Office and related tools.

Physical Requirements

• Regularly required to stand and walk for extended periods on hard warehouse and production flooring.
• Frequently required to bend, stoop, kneel, and reach in upward and downward directions.
• Occasionally lift or move up to 50 lbs; frequently lift or move up to 40 lbs.
• Push and pull loaded carts, pallet jacks, and hand trucks across production surfaces.
• Safely climb ladders to access materials stored at height.
• Operate powered industrial equipment including forklifts and electric pallet jacks, managing vibration exposure and repetitive upper‑body movement.
• Work in varying temperature environments, including ambient, refrigerated, and frozen storage areas, using appropriate PPE.
• Wear full cleanroom gowning for extended periods as required by the production area.
• Maintain vision requirements—close, distance, peripheral, depth perception, and readability of small print on labels and documents.

August Bioservices is an equal opportunity employer and values diversity.