Senior Technology Transfer MS&T Engineer

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 is a core team member for customer facing collaborations. An extensive understanding of pharmaceutical sterile processing principles, process development and scale‑up approaches is required. Knowledge and expertise in Biologics are preferred with experience in single‑use system (SUS) technologies and compliant process segregation as an important core service August Bioservices provides to clients.

Technical understanding and application of current equipment, process controls, identification of support utilities and sampling technologies is an important competency as they relate to development, optimization, and technology transfer of small and large molecule fill/finish operations.

The incumbent is responsible for 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 science‑driven solutions to any technology transfer process.

In addition, the individual in this role is responsible for working on multiple client‑based projects in a fast‑paced environment. Apart from technology transfer activities, the position requires writing of technical documents to support, including protocols, reports, SOPs, work instructions, batch records and technical and risk assessments. The engineer is expected to work with other technical services/process engineers to support process development within a team‑based environment and serve as the primary contact for the operations team throughout the product’s lifecycle.

The engineer is supported directly by facility engineers as required.

• Review technology transfer documents such as product development reports, batch manufacturing and/or packaging records to provide 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.
• 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 execution of toxicological, clinical, scale‑up, exhibit/registration, commercial and process performance qualification with production team inside production areas.
• Lead the evaluation and selection of new equipment in support of fill/finish production operations in collaboration with client and internal stakeholders.
• Work with R&D, Facilities and Validation team 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 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 analyze corrective actions and provide support.
• Write comprehensive technical reports, business evaluations, process descriptions with or without supervision.
• Write documents including master batch records, protocols, reports, SOPs, work instructions, and other necessary technical documents.
• Troubleshoot and resolve simple to moderately complex issues, diagnosing technical problems and identifying short‑ and long‑term solutions.
• Work with cross‑functional team leads to identify opportunities for enhancements and champion projects that will improve overall site function.
• Proficient in quality‑system software such as Master Control and related tasks such as MOC (change control), CAPA, issue reviews, work orders,…