Bioprocess Tech Transfer Lead - Staff Engineer

Dexian; Franklin (TN); On-site; USD 120,000 - 180,000; Full time

Job summary

Dexian seeks a Staff Product Transfer Project Engineer Bioprocessing to lead complex biologics technology transfer programs between CMOs and internal sites. You will oversee process development, transfer, validation, and regulatory support across sterile biologics manufacturing, with emphasis on compliance and readiness for commercial production.

The role requires strong bioprocessing knowledge, at least 4 years in biotech or pharma, and experience working with CMOs in FDA-regulated

Qualifications

• Strong understanding of biologics manufacturing and bioprocessing.
• Experience with FDA/EMA/ICH and cGMP regulatory environments.
• Proven ability to lead cross-functional teams through tech transfer.

Responsibilities

• Lead end-to-end bioprocess technology transfer activities including scale-up and qualification.
• Serve as engineering liaison between CMOs and internal teams (Regulatory, QA, Manufacturing).
• Coordinate risk assessments (e.g., FMEA) and support regulatory submissions.
• Manage ECOs/change controls and ensure timely, compliant transfer activities.
• Support analytical method transfers, IQ/OQ/PQ, and PPQ campaigns.

Skills

Bioprocessing knowledge

Project management

Regulatory understanding

Communication skills

Education

MS or PhD in Chemistry/Biochemistry/Pharmaceutical Sciences/Biotechnology/Engineering

Job description

Dexian seeks a Staff Product Transfer Project Engineer Bioprocessing to lead complex biologics technology transfer programs between CMOs and internal sites. You will oversee process development, transfer, validation, and regulatory support across sterile biologics manufacturing, with emphasis on compliance and readiness for commercial production.

The role requires strong bioprocessing knowledge, at least 4 years in biotech or pharma, and experience working with CMOs in FDA-regulated