Associate Director - Biologics ExM Engineering (Remote)

Merck; Little Rock (AR); Remote; USD 142,000 - 224,000; Full time

Job summary

Merck is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology. Based in the US, you will lead technical transfers to External Partners and ensure on-time, within-budget delivery of manufacturing processes and continuous improvement across the biologics network.

You will collaborate across functions to support new product transfers, drive risk mitigation, and optimize process performance while navigating a complex, global partner network.

Qualifications

• Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
• Minimum of 8 (eight) 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 is required

Responsibilities

• Provides a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.
• Provides technical oversight, management, and planning support for complex partnership models. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues
• Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.
• Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
• Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partner(s) for inclusion in the Company Network. Executes technical due diligence assessments at External Partner(s).
• Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
• Leads team for identification and assessment of partner risks and develops mitigations plans.
• Develops and executes validation strategies for new and existing products.
• Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
• Ensures targeted communications and alignment across technical functions. Guides and coaches' others in change leadership.
• Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites
• Determines resource plans across all relevant technical functions.
• Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes. Minimizes duplication of efforts between External Partner and Company systems.
• Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility
• In concert with Commercialization, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers.
• Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
• Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both Our Company and EP.

Skills

Technical transfers

Cross-functional leadership

Lean Manufacturing

Problem solving

Leadership

Change management

Interpersonal skills

Collaboration

Strategic thinking

Technical review

Education

Bachelor's degree in Engineering or Science

8+ years post-bachelor’s in biologics/drug substance

Tools

Job description

Merck is seeking an Associate Director, Engineering within Biologics External Manufacturing Technology. Based in the US, you will lead technical transfers to External Partners and ensure on-time, within-budget delivery of manufacturing processes and continuous improvement across the biologics network.

You will collaborate across functions to support new product transfers, drive risk mitigation, and optimize process performance while navigating a complex, global partner network.