Associate Director, Engineering

🔥 0 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🖥 Software Engineer

👻 Ghost score 10%

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Lead and act as the primary interface on technical issues between technical operations and external partners • Provide technical leadership for commercialization and manufacture of drug substance • Provide technical guidance to external partners and assess proposed process configurations and standards adherence • Collaborate with procurement, external manufacturing operations, external quality, regulatory, and other teams to evaluate external partners • Execute technical due diligence assessments at external partners • Execute technical transfers and receiving-site readiness activities • Identify and assess partner risks and develop mitigation plans • Execute validation strategies for new and existing products • Support external partners in resolving production issues and optimizing process and capacity • Support, coordinate, and manage complex investigations • Review external partner process change requests, deviations, and master batch record changes • Drive continuous process verification and process performance monitoring for assigned products • Partner with operations, quality, and external partners to meet regulatory requirements efficiently • Support external large molecule drug substance manufacturing activities across the external manufacturing network

🎯 Requirements

• Bachelor’s degree in engineering, biological/chemistry sciences, or related discipline • Minimum of 10 years of relevant work experience in manufacturing, including process start-up, routine manufacturing, and/or technical transfer • Minimum of 5 years of experience in Drug Substance, including leading Drug Substance Technical Transfers and/or commercial manufacturing • Ability to work effectively across boundaries and build collaborative relationships with internal teams and external partners • Strong professional and interpersonal communication skills • Authentic and inclusive people leadership, with ability to engage others and create a psychologically safe, collaborative culture • Ability to multitask and work within tight deadlines • Experience with change control procedures and systems • Ability to work independently and strong organizational skills • Strong knowledge of Quality systems, Drug Substance Manufacturing, and Validation • Strong analytical problem-solving, root cause analysis, and risk assessment/mitigation skills • Excellent command of English, written and oral • Experience in mAb DS production preferred • Experience in conjugation processes preferred • Lean Manufacturing / Six Sigma experience preferred • Project management experience preferred • Knowledge of worldwide regulatory requirements and experience supporting regulatory inspections preferred

🏖️ Benefits

• Remote work arrangement • Relocation: No relocation • Travel requirements: 10–20% periodic travel stated in the role description • Temporary (Fixed Term) employee status