Senior Technology Transfer MS&T Engineer
About the role
August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO) headquartered in Nashville, TN. We provide a wide range of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, playing a vital role in the global pharmaceutical industry.
Responsibilities
Review of technology transfer documents such as product development reports, batch manufacturing and/or packaging records to provide the technical analysis for the overall process
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 SOP and work instructions
Lead and/or support execution of Toxicological, Clinical, Scale up, Exhibit/Registration, Commercial and process Performance Qualification with production team inside production areas
Work with R&D, Facilities and Validation team on process implementation to develop a detailed plan based on the approved scope of work
Conduct phase specific studies based on DOE (Design of Experiments) as needed, for formulation optimization and process confirmation
Incorporate Quality-By-Design (QbD) approach in the product development program to improve the drug formulation and manufacturing process
Investigate and Corrective Actions analysis and support
Write comprehensive technical reports, business evaluations, process description with or without supervision
Write documents including master batch records, protocols and reports, SOPs, Work Instructions, and other necessary technical documents
Resolve simple to moderately complex issues, diagnosing technical problems and identifying short and long-term solutions
Champion projects which will improve overall site function
Qualifications
B.S in Pharmaceutical Sciences (or equivalent), M.S in Pharmaceutical Sciences (or equivalent), or PhD 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
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 appropriate process requirements for sterile operations including: compounding, sterile filtration, aseptic formulation, sterile filling for vials, pre-filled syringes and flexible IV bags
Software proficiency in Minitab® (or equivalent), Microsoft Office® etc