Associate Technology Transfer Engineer (MSAT) in Nashville, Tennessee at August Bioservices

The Associate Technology Transfer Engineer is responsible for assigned tasks associated with the technology transfer for sterile drug products and Biologics. The responsibilities include working with Formulation Development, Process Engineers, Analytical Development, Production, Quality, and Regulatory to identify product and process criticalities and finding scientific data driven solutions to any Technology Transfer process. 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.

Apart from supporting Technology Transfer activities, the position requires writing of technical documents to support, including protocols, reports, SOPs, Work Instruction, Batch records, and technical and risk assessments. The Engineer is this role is expected to work with other Technology technical services/process engineers to support process development within a team-based environment. This position will be responsible for participating in interdisciplinary teams and primary contact for the operations team throughout the product’s lifecycle. The Engineer is supported directly by more experienced Technology Transfer Engineers and departmental leadership as required.

• 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.
• Based on analysis, 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 SME’s training and familiarization efforts for new processes and equipment including development of operation SOP and work instructions for assigned projects
• 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
• Support the evaluation and selection of new equipment in support of fill/finish production operations in collaboration with client and internal stakeholders.
• 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 product and processes
• Support execution of phase specific studies based on DOE (Design of Experiments) as needed, for formulation optimization and process confirmation.
• Apply elements of Quality-By-Design (QbD) approach in the product development program to improve the drug formulation and manufacturing process with support from more experienced team members or SME’s.
• Contribute to Investigations and Corrective Actions analysis and support.
• Write comprehensive technical reports, business evaluations, process description with supervision where required.
• Support revisions to documents including master batch records, protocols and 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 technical problems and identifying short and long-term solutions
• Working with Cross-Functional Team leads to identifying opportunities for enhancements and champion projects which will improve overall site function.
• Aptitude to learn and apply Quality system software such as Master control and related task such MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents.

• The candidate requires B.S in Pharmaceutical Sciences (or equivalent), M.S in Pharmaceutical Sciences (or equivalent), or PhD in Pharmaceutical Sciences (or equivalent).

• The candidate requires B.S in Pharmaceutical Sciences (or equivalent) with 1-2 year of experience, M.S in Pharmaceutical Sciences (or equivalent) with <1 year of experience, or PhD in Pharmaceutical Sciences (or equivalent) with <1 year of experience.

• Knowledge of general pharmaceutical manufacturing unit operations.
• Knowledge of general pharmaceutical processing technologies such as mixers, transfer pumps, 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
• Software: Minitab® (or equivalent), Microsoft Office® etc., Microsoft Visio

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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

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.