Sterile Biologics Tech Transfer Engineer

August-Bioservices; Nashville (TN); On-site; USD 80,000 - 110,000; Full time

Job summary

August Bioservices in Nashville, TN is seeking an Associate Technology Transfer Engineer to support sterile drug product and biologics technology transfer from development through scale-up.

You will collaborate with Formulation Development, Process Engineers, Analytical Development, Production, Quality and Regulatory to identify key process criticalities, draft technical documents, and help ensure compliant and efficient transfer workflows.

Qualifications

• Bachelor’s, Master’s, or PhD in Pharmaceutical Sciences or equivalent.
• BS with 1–2 years of experience, MS with <1 year, or PhD with <1 year.

Responsibilities

• Review technology transfer documents and provide the technical analysis for the overall process.
• Identify gaps in capabilities to support new product introductions and recommend solutions.
• Support data collection during development and scale-up activities and propose process optimization opportunities.
• Develop operation SOPs and work instructions for assigned projects with SME guidance.
• Assist in phase-specific studies (DOE) for formulation optimization and process confirmation.
• Write technical reports, protocols, and batch records with supervision.

Skills

Tech transfer

Sterile operations

Data analysis

GMP knowledge

Education

B.S. in Pharmaceutical Sciences

M.S. in Pharmaceutical Sciences

PhD in Pharmaceutical Sciences

Tools

Minitab

Microsoft Office

Microsoft Visio

Job description

August Bioservices in Nashville, TN is seeking an Associate Technology Transfer Engineer to support sterile drug product and biologics technology transfer from development through scale-up.

You will collaborate with Formulation Development, Process Engineers, Analytical Development, Production, Quality and Regulatory to identify key process criticalities, draft technical documents, and help ensure compliant and efficient transfer workflows.