August Bioservices, LLC · 1 day ago
Technology Transfer MS&T Engineer
Nashville, TN
Full-time
Onsite
Mid Level
3+ years expAugust Bioservices is a high-growth Contract Development Manufacturing Organization based in Nashville, TN, specializing in drug discovery, formulation, and manufacturing services for the pharmaceutical industry. The Technology Transfer MS&T Engineer will serve as a Technical Services expert, responsible for technology transfer of sterile drug products and Biologics, collaborating with various teams to optimize processes and ensure compliance.
BiotechnologyMedicalPharmaceutical
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
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
Investigations 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
Troubleshoot and resolve simple to moderately complex 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
Proficient in 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
Qualification
Required
B.S in Pharmaceutical Sciences (or equivalent), M.S in Pharmaceutical Sciences (or equivalent), or PhD in Pharmaceutical Sciences (or equivalent)
3+ 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
Experience in developing technical recommendations in support of new process introductions
An extensive understanding of pharmaceutical sterile processing principles, process development and scale-up approaches
Technical understanding and application of current equipment, process controls, identification of support utilities and sampling technologies as they relate to development, optimization, and technology transfer of small and large molecule fill/finish operations
Proficient in Quality system software such as Master control and related tasks such as MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents
Preferred
Knowledge and expertise in Biologics
Experience in single-use system (SUS) technologies and compliant process segregation
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: Minitab® (or equivalent), Microsoft Office® etc
Company
August Bioservices, LLC
August Bioservices, a leading sterile injectable CDMO headquartered in Nashville, Tennessee, delivers end-to-end contract development and manufacturing services for pharmaceutical and biotech clients.
51-200 employees
H1B Sponsorship
August Bioservices, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (11)
2023 (12)
2022 (2)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$88.6MKey Investors
Oak HC/FTPolaris Partners
2022-12-01Series B· $65M
2021-05-27Series A· $23.6M
2020-07-16Series Unknown
Leadership Team
Mats Bjoerkman
Chief Financial Officer
Colette Lanzon
Talent Acquisition Business Partner
Recent News
Seattle TechFlash
2025-06-24
The Business Journals
2024-02-11
Company data provided by crunchbase