Senior Lead, Large Molecule Tech Transfer & Network

Merck

Elkhorn Precinct (NE)

Hybrid

USD 142,000 - 224,000

Full time

5 days ago
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Benefits offered by this job

Medical, dental, vision coverage
401(k) retirement benefits
Paid holidays and vacation
Sick days and compassionate leave

Job summary

Merck is seeking a Large Molecule (LM) drug substance leader to oversee LM drug substance portfolio within a global CMO network. You will manage tech transfer, development, scale-up, and lifecycle, partnering with external suppliers and internal teams to ensure on-time delivery and continuous process improvements.

The role emphasizes global leadership, strategic planning, and strong communication across regulatory, quality, and operations.

Qualifications

  • Minimum 10 yrs. of relevant experience.
  • Experience in development of viral vaccines and LM drug substances including monoclonal antibodies, antigens, ADCs, mRNA, etc.
  • A minimum of 5 years in LM process development roles.
  • Strong business acumen, communication skills, and project management experience.
  • Global leadership and cross-functional collaboration skills.

Responsibilities

  • Lead LM drug substance portfolio management in global CMOs with focus on tech transfer, scale-up, production and lifecycle management.
  • Own end-to-end execution of supplier-driven transfer or development projects.
  • Coordinate with Network, Global Procurement, S&T, QA and internal sites for transfers and development.
  • Lead cross-functional meetings, track changes and deviations, drive process improvements.
  • Develop technical packages and perform supplier due diligence for selection.

Skills

Biologics
GMP
Manufacturing
Process Development
Product Transfers
Project Leadership
Project Management Leadership
Technical Transfer
Technology Transfer
Vaccine Manufacturing
Vaccine Production
Vendor Evaluations

Education

Bachelor's degree in Biochemistry, Biochemical Engineering, Bioprocess Engineering or comparable

Tools

Microsoft Project
Primavera

Job description

Merck is seeking a Large Molecule (LM) drug substance leader to oversee LM drug substance portfolio within a global CMO network. You will manage tech transfer, development, scale-up, and lifecycle, partnering with external suppliers and internal teams to ensure on-time delivery and continuous process improvements.

The role emphasizes global leadership, strategic planning, and strong communication across regulatory, quality, and operations.

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