5 years experience in drug substance manufacturing
Leading new product introduction and technical transfers
Merck & Co., Inc. is seeking an Associate Director of External Manufacturing to support drug substance manufacturing within their External Manufacturing Network. The role involves technical leadership, collaboration with external partners, and oversight of manufacturing processes to ensure quality and compliance
Job Summary
This role serves as the primary technical interface between internal operations and external manufacturing partners to support drug substance manufacture.
The successful candidate will lead technical due diligence assessments, execute validation strategies, and ensure successful tech transfers for commercialization.
The team fosters a collaborative culture focused on continuous improvement, innovation, and proactive risk management within the small molecule line of business.
Matching Summary
Match Score: 85
Merck & Co., Inc. is seeking an Associate Director of External Manufacturing to support drug substance manufacturing within their External Manufacturing Network. The role involves technical leadership, collaboration with external partners, and oversight of manufacturing processes to ensure quality and compliance.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
7 years relevant work experience in manufacturing
5 years experience in drug substance manufacturing
Leading new product introduction and technical transfers
Process development scale up and robustness
Root cause analysis and risk assessment mitigation
Nice-to-have
Lean Manufacturing or Six Sigma experience
Knowledge of flow chemistry and bio-catalysis
Project management experience
Experience supporting regulatory inspections
Inclusive people leadership skills
Key Requirements
Bachelor's degree in engineering or chemistry sciences
Minimum 7 years of relevant manufacturing experience
Minimum 5 years of drug substance experience
Strong knowledge of quality systems and validation