Associate Director, Engineering

🕒 June 16

🏄 California, Pennsylvania – Remote

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💵 $142.4k - $224.1k / year

⏰ Full Time

🟠 Senior

🖥 Software Engineer

🦅 H1B Visa Sponsor

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👻 Ghost score 45%

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Logo of MSD

MSD

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

• Serve as the key technical leader and interface between the company and Biologics External Manufacturing partners • Create, lead, and execute technical transfers and commercial supply activities • Provide a single point of technical contact to assigned External Partners, Company Manufacturing Division sites, and Commercialization • Provide technical oversight, management, planning, coordination, communication, and issue resolution for complex partnership models • Deliver technology transfers on time and within budget while coordinating resources with Operations Unit leadership • Provide technical guidance, assess process technology viability, verify standards adherence, and ensure technically sound deliverables • Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and other functions to evaluate External Partners • Execute technical due diligence assessments at External Partners • Lead receiving-site readiness activities and ensure successful business outcomes for technology transfers • Lead partner risk identification and assessment and develop mitigation plans • Develop and execute validation strategies for new and existing products • Provide manufacturing process support to resolve production issues and optimize process and capacity • Ensure communication and alignment across technical functions and coach others in change leadership • Support, coordinate, and manage complex investigations • Determine resource plans across relevant technical functions • Review External Partner process change requests, deviations, and Master Batch Record changes • Drive continuous process verification and process performance monitoring programs • Ensure External Partners are inspection-ready for new product introductions and transfers • Partner with Operations, Quality, and External Partners to meet regulatory requirements efficiently • Collaborate with External Partners to achieve business goals and establish a common culture • Report to the Director, Biologics External Manufacturing Technology

🎯 Requirements

• Bachelor’s degree in Engineering or applicable Science is required • Minimum of 8 years post-bachelor’s degree experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations • Expertise and demonstrated accomplishments leading technical transfers • Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues • Excellent leadership, collaboration, change management, interpersonal, analytical, and communication skills • Ability to motivate a team around a common vision and deliver expected results • Experience in biologics manufacturing, broad process sciences and analytics, strong leadership skills, business acumen, and interpersonal skills • Expertise with Automation Systems, Capital Project Management, Clinical Manufacturing, Data Analysis, Drug Product Manufacturing, Lean Manufacturing, Manufacturing Scale-Up, Regulatory Compliance, Root Cause Analysis, and Technical Transfer • Travel and flexibility in partner assignment location required; travel requirements exceed 30% and are listed as 50% • US and Puerto Rico residents only • Visa sponsorship is not available • Valid driving license is not required

🏖️ Benefits

• Annual bonus • Long-term incentive, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate days • Sick days • Remote work arrangement • Domestic relocation

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