Director, Assembly and Packaging Platform Technical Leadership

Merck Merck · Pharma · PA

This role is for a Director of Assembly and Packaging Platform Technical Leadership at Merck, a biopharmaceutical company. The position requires extensive experience in pharmaceutical packaging and combination product assembly, with a focus on technical leadership, process improvement, risk management, and regulatory compliance. The role involves leading technical teams, ensuring scientific rigor, and managing technical support for packaging platforms from early stage through launch and supply. It is not directly related to AI/ML development.

What you'd actually do

  1. Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
  2. Provide subject matter expertise and ensure scientific rigor, technical problem solving, and execution excellence across the assembly and packaging platform portfolio.
  3. Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
  4. Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support and platform stewardship.
  5. Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities.

Skills

Required

  • packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields
  • pharmaceutical packaging
  • combination product assembly and packaging
  • medical device and combination product commercialization and tech transfer
  • assembly and packaging process improvement and support
  • leadership role; managing technical teams supporting packaging
  • combination product assembly & packaging
  • problem-solving and decision-making skills
  • global regulatory requirements for medical devices and combination products and packaging
  • risk management principles, including ISO 14971
  • strategic and analytical thinking
  • continuous improvement
  • best practices in technical support and product stewardship
  • communication and interpersonal skills

Nice to have

  • Accountability
  • Change Management
  • Cold Chain
  • Cold Chain Logistics
  • Cold Chain Management
  • Cold Chain Packaging
  • Combination Products
  • Compliance Packaging
  • Cross-Cultural Awareness
  • Data-Driven Decision Making
  • Design Verification Testing
  • Distribution Network Optimization
  • Domestic Corporate Compliance
  • Driving Continuous Improvement
  • Engineering Standards
  • GMP Compliance
  • Gross Domestic Product
  • Innovation
  • Leadership
  • Leadership Project Management
  • Manufacturing Scale-Up
  • Materials Design
  • Materials Engineering
  • Mentorship

What the JD emphasized

  • fifteen (15) years relevant experience
  • twelve (12) years relevant experience
  • eight (8) years relevant experience
  • In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging.
  • Strong understanding of risk management principles, including ISO 14971 and other relevant standards.