Associate Technology Transfer Engineer (MSAT)

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, we provide a wide array 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. Our work helps 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.

About the role

The Associate Technology Transfer Engineer is responsible for assigned tasks associated with the technology transfer for sterile drug products and Biologics. This includes working with Formulation Development, Process Engineers, Analytical Development, Production, Quality, and Regulatory to identify product and process criticalities and finding scientific data-driven solutions. Associate Technology Transfer Engineers will generally lead maintenance of more established programs or support more experienced leads in designing and implementing more complex New Product Introductions.

This position requires writing technical documents to support protocols, reports, SOPs, Work Instructions, Batch records, and technical and risk assessments. The Engineer will work with other Technology technical services/process engineers to support process development within a team-based environment, participating in interdisciplinary teams and serving as the primary contact for the operations team throughout the product’s lifecycle.

Responsibilities

• Review technology transfer documents such as product development reports, batch manufacturing, and/or packaging records to provide technical analysis for the overall process.
• Identify gaps in capabilities needed to support new product/process introductions and recommend solutions to close these gaps.
• Support the evaluation of collected data during development and scale-up activities and recommend opportunities for process optimization for assigned projects.
• Work with leads or established SMEs on training and familiarization efforts for new processes and equipment, including development of operational SOPs and work instructions.
• Support execution of Toxicological, Clinical, Scale-up, Exhibit/Registration, Commercial manufacturing, and process Performance Qualification/Validations with the production team inside production areas.
• Support or lead the identification and procurement request process of materials recommended for assigned client projects.
• Maintain a clean, organized, and documentation-compliant R&D laboratory and pilot-scale spaces, including proper storage and labeling of materials specific to client projects.
• Support the evaluation and selection of new equipment in collaboration with clients and internal stakeholders for fill/finish production operations.
• Participate in multidisciplinary project teams through the complete product transfer journey to support ongoing client projects on-time.
• Identify opportunities to recommend additional value-added services through sound technical evaluation of client products and processes.
• Support execution of phase-specific studies based on DOE (Design of Experiments) for formulation optimization and process confirmation.
• Apply elements of Quality-By-Design (QbD) in the product development program to improve drug formulation and manufacturing processes with support from experienced team members or SMEs.
• Contribute to Investigations and Corrective Actions analysis and support.
• Write comprehensive technical reports, business evaluations, and process descriptions with supervision where required.
• Support revisions to documents including master batch records, protocols, reports, SOPs, Work Instructions, and other necessary technical documents.
• Support peer review and approval of protocols, batch records, and summary reports.
• Troubleshoot and resolve less complex technical issues, diagnosing problems and identifying short and long-term solutions.
• Work with Cross-Functional Team leads to identify opportunities for enhancements and champion projects that improve overall site function.
• Learn and apply Quality system software such as MasterControl and related tasks such as MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents.

Requirements

• B.S. in Pharmaceutical Sciences (or equivalent) with 1-2 years of experience, or
• M.S. in Pharmaceutical Sciences (or equivalent) with less than 1 year of experience, or
• PhD in Pharmaceutical Sciences (or equivalent) with less than 1 year of experience.

Skills

• Knowledge of general pharmaceutical manufacturing unit operations.
• Knowledge of general pharmaceutical processing technologies such as mixers, transfer pumps, and temperature control devices.
• Knowledge of general process requirements for sterile operations including: compounding, sterile filtration, aseptic formulation, sterile filling for vials, pre-filled syringes, and flexible IV bags.
• Proficiency in software: Minitab® (or equivalent), Microsoft Office®, Microsoft Visio.

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at times.