Aseptic Tech Transfer MS&T Engineer (Biologics)

Augustbio; Nashville (TN); On-site; USD 95,000 - 140,000; Full time

Job summary

August Bioservices seeks a Technology Transfer MS&T Engineer to lead aseptic transfer for sterile products and Biologics. You will work with Formulation Development, Process Engineers, Analytical Development, Production, Quality, and Regulatory to drive science-based solutions and robust transfer strategies.

The role covers multiple client projects, writing protocols, reports, SOPs, batch records, and risk assessments within a fast-paced, team-based environment.

Qualifications

• BS/MS/PhD in Pharmaceutical Sciences or equivalent.
• 5+ years of equivalent pharmaceutical experience.
• Experience with aseptic process implementation and GMP in production.

Responsibilities

• Review technology transfer documents and provide technical analysis.
• Identify gaps and recommend solutions for new product introductions.
• Lead data evaluations for development and scale-up activities.
• Develop operation SOPs and work instructions for new processes.
• Lead or support QC/PQ activities with production teams.
• Collaborate with R&D, Facilities, Validation and Regulatory teams.

Skills

Technology transfer

Aseptic processing

Scale-up strategies

Biologics knowledge

SUS technologies

DOE (Design of Experiments)

QbD (Quality-by-Design)

Cross-functional collaboration

Technical writing

Education

BS in Pharmaceutical Sciences

MS in Pharmaceutical Sciences

PhD in Pharmaceutical Sciences

Tools

MasterControl

Minitab

Microsoft Office

Job description

August Bioservices seeks a Technology Transfer MS&T Engineer to lead aseptic transfer for sterile products and Biologics. You will work with Formulation Development, Process Engineers, Analytical Development, Production, Quality, and Regulatory to drive science-based solutions and robust transfer strategies.

The role covers multiple client projects, writing protocols, reports, SOPs, batch records, and risk assessments within a fast-paced, team-based environment.