August Bioservices

Senior Technology Transfer MS&T Engineer

Nashville, Tennessee · Senior

Sponsorship not specifiedDetected 11 days ago

Process ImprovementGMPCollaborationMicrosoft Office

About the role

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).
August Bioservices is seeking a Technology Transfer MS&T Engineer (Technical Services) reporting to the Sr.
The candidate will serve as a Technical Services expert for aseptic process implementations and is a core team member for customer facing collaborations.

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.
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.
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.

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.
Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures.
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
Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
An extensive understanding of pharmaceutical sterile processing principles, process development and scale-up approaches is required.
The Engineer is supported directly by facility engineers as required.

For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

This listing is sourced directly from August Bioservices's careers page and normalized into a canonical job model.