Senior Vector Process Scientist & Tech Transfer Lead

US WorldMeds, LLC; Philadelphia, Northern (Philadelphia County, KY); Hybrid; USD 104,000 - 148,000; Full time

Job summary

US WorldMeds, LLC is seeking a Principal Scientist (Vector) in Philadelphia to lead MSAT efforts for viral-vector manufacturing. The role focuses on technology transfer, process optimization, aseptic validation, and BLA support, bridging internal DS/DP with outsourced vector production to ensure quality and regulatory compliance.

The candidate should bring deep LVV/AAV knowledge, strong project management, and ability to drive audits, CAPAs, and continuous improvement across multi-disciplinary

Qualifications

• PhD: 4+ years; MS: 8+ years; BS: 10+ years of industry experience.
• Aseptic techniques and regulatory validation experience (FDA/EU).
• Experience with cGMP, Annex 1, and ATMP guidance for manufacturing processes.
• Cross-functional collaboration to perform process transfer for cGMP production.
• Project management and resource planning capabilities.
• Strong knowledge of AAV or LVV production is required.
• Experience managing CROs/CMOs and regulatory submissions (IND, BLA, MAA).

Responsibilities

• Provide technical leadership for technology transfer and process optimization.
• Develop and execute phase-appropriate studies for product characterization.
• Lead lifecycle management for CGT programs and CGT-related validation.
• Collaborate with QA, Regulatory Affairs, Analytical Sciences, Supply Chain, and Facilities.
• Utilize SPC tools to monitor manufacturing metrics and ensure audit readiness.
• Mentor junior scientists and potentially manage a small to mid-sized team.
• Interface with external CMOs/CDMOs for LVV production and related programs.

Skills

Aseptic techniques

Regulatory knowledge

Cross-functional collaboration

Project management

QbD and statistical data analysis

Lentiviral/LVV knowledge

Education

B.S./M.S./Ph.D. in life sciences or engineering

Job description

US WorldMeds, LLC is seeking a Principal Scientist (Vector) in Philadelphia to lead MSAT efforts for viral-vector manufacturing. The role focuses on technology transfer, process optimization, aseptic validation, and BLA support, bridging internal DS/DP with outsourced vector production to ensure quality and regulatory compliance.

The candidate should bring deep LVV/AAV knowledge, strong project management, and ability to drive audits, CAPAs, and continuous improvement across multi-disciplinary