Senior Manager, External Drug Substance Manufacturing

MSD; Rahway (NJ); Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Merck & Co., Inc. in the United Kingdom is seeking a Senior Manager to lead technical operations for drug substance manufacturing within an external manufacturing network. You will partner with external partners to ensure robust tech transfer, process scale-up, and validated processes.

The role requires 7+ years in manufacturing, strong regulatory and quality systems knowledge, and the ability to travel up to 50%. Hybrid work arrangement with external partners is expected.

Qualifications

• Bachelor’s degree in engineering, chemistry, or related field with 7+ years in manufacturing.
• 5+ years in drug substance with leading drug substance new product introduction, tech transfers, and commercial manufacturing.
• Strong problem-solving, root cause analysis, and risk assessment/mitigation skills.
• Ability to lead across internal and external teams and manage stakeholders.
• Excellent English communication; travel ~50%.

Responsibilities

• Lead and act as the primary interface on technical issues between technical operations and external partner.
• Provide technical leadership for commercialization and manufacture of drug substance.
• Guide external partner on process viability, standards, and deliverables.
• Collaborate with external manufacturing, QA, regulatory to evaluate performance and drive continuous improvement.
• Execute tech transfers and site readiness activities; validate strategies for new and existing products.

Skills

Process development

Scale-up

Tech transfers

Problem solving

Stakeholder management

Leadership

Regulatory knowledge

Education

Bachelor's degree

Tools

Process validation

Job description

Merck & Co., Inc. in the United Kingdom is seeking a Senior Manager to lead technical operations for drug substance manufacturing within an external manufacturing network. You will partner with external partners to ensure robust tech transfer, process scale-up, and validated processes.

The role requires 7+ years in manufacturing, strong regulatory and quality systems knowledge, and the ability to travel up to 50%. Hybrid work arrangement with external partners is expected.