Associate Director, LM External Manufacturing & Viral Tech

HireLifeScience; Elkhorn Precinct (NE); Hybrid; USD 142,000 - 224,000; Full time

Job summary

HireLifeScience seeks a Senior LM Drug Substance Leader to manage external manufacturing for viral product pipelines. The role focuses on tech transfer, process development, scale-up, and lifecycle management across global supplier networks.

You will drive collaboration between S&T, QA, regulatory, and procurement to ensure on-time delivery and compliance. The position demands robust leadership, strategic thinking, and travel, with a hybrid work model in the US.

Qualifications

• Bachelor's degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable.
• Minimum 10 years of relevant experience in LM/drug substance contexts.
• Experience in viral vaccine development and LM drug substances (e.g., mAbs, antigens, ADCs, mRNA).
• At least 5 years in LM process development roles.
• Strong business acumen, communication, and proven project management skills.
• Global leadership with cross-functional, end-to-end supply chain perspective.

Responsibilities

• Lead LM drug substance tech transfer and development across global CMOs.
• Manage supplier selection, technical due diligence, and lifecycle management.
• Oversee end-to-end execution from tech transfer to in-line supply.
• Coordinate with network, procurement, QA, and regulatory teams.
• Drive process development, innovations, and cost reduction initiatives.
• Lead cross-functional meetings and manage deviations and changes.

Skills

GMP

Process Development

Project Leadership

Technical Transfer

Vaccine Manufacturing

Vendor Evaluations

Product Transfers

Manufacturing

Regulatory Strategies

Microsoft Project

Primavera

Education

Bachelor's degree in Biochemistry/Biochemical Engineering/Bioprocess Engineering

PhD in Biochemistry/Biochemical Engineering/Bioprocess Engineering (preferred)

Tools

Microsoft Project

Primavera

Job description

HireLifeScience seeks a Senior LM Drug Substance Leader to manage external manufacturing for viral product pipelines. The role focuses on tech transfer, process development, scale-up, and lifecycle management across global supplier networks.

You will drive collaboration between S&T, QA, regulatory, and procurement to ensure on-time delivery and compliance. The position demands robust leadership, strategic thinking, and travel, with a hybrid work model in the US.