Director, Assembly and Packaging Platform Technical Leadership
Merck
3 hours ago
Remote friendly (West Point, PA)
United States
Operations
Responsibilities:
- Lead, mentor, and develop a team of technical staff, fostering continuous improvement.
- Provide subject matter expertise and ensure scientific rigor, technical problem solving, and execution excellence across the assembly and packaging platform portfolio.
- Drive proactive risk management (risk assessment, mitigation, and communication).
- Partner with internal stakeholders to enable technical support and platform stewardship.
- Develop and maintain KPIs to improve platform stewardship effectiveness.
- Provide strategic leadership for technical support, managing ongoing changes and tech transfers.
- Guide lifecycle packaging platform changes to meet internal requirements and support regulatory filings for compliance.
Qualifications (Required):
- BS in packaging/mechanical/chemical/biochemical engineering, pharmaceutical science or chemistry (15+ years relevant experience) OR
- MS in related fields (12+ years) OR
- PhD in related fields (8+ years)
- Expertise in medical device/combination product commercialization and tech transfer; assembly & packaging process improvement from early stage through launch and supply.
- Leadership experience managing technical teams supporting packaging and combination product assembly/packaging.
- Strong problem-solving/decision-making; ability to interrogate science and identify true requirements.
- In-depth knowledge of global regulatory requirements for medical devices and combination products.
- Risk management knowledge (e.g., ISO 14971).
- Strong communication and interpersonal skills.
Required/Relevant skills:
- Accountability, change management, risk management, GMP compliance, driving continuous improvement, leadership, leadership project management.
Benefits (explicitly stated): medical/dental/vision insurance, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub for current employees). Apply by the deadline stated on the posting (Job posting end date: 05/4/2026).
- Lead, mentor, and develop a team of technical staff, fostering continuous improvement.
- Provide subject matter expertise and ensure scientific rigor, technical problem solving, and execution excellence across the assembly and packaging platform portfolio.
- Drive proactive risk management (risk assessment, mitigation, and communication).
- Partner with internal stakeholders to enable technical support and platform stewardship.
- Develop and maintain KPIs to improve platform stewardship effectiveness.
- Provide strategic leadership for technical support, managing ongoing changes and tech transfers.
- Guide lifecycle packaging platform changes to meet internal requirements and support regulatory filings for compliance.
Qualifications (Required):
- BS in packaging/mechanical/chemical/biochemical engineering, pharmaceutical science or chemistry (15+ years relevant experience) OR
- MS in related fields (12+ years) OR
- PhD in related fields (8+ years)
- Expertise in medical device/combination product commercialization and tech transfer; assembly & packaging process improvement from early stage through launch and supply.
- Leadership experience managing technical teams supporting packaging and combination product assembly/packaging.
- Strong problem-solving/decision-making; ability to interrogate science and identify true requirements.
- In-depth knowledge of global regulatory requirements for medical devices and combination products.
- Risk management knowledge (e.g., ISO 14971).
- Strong communication and interpersonal skills.
Required/Relevant skills:
- Accountability, change management, risk management, GMP compliance, driving continuous improvement, leadership, leadership project management.
Benefits (explicitly stated): medical/dental/vision insurance, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or via Workday Jobs Hub for current employees). Apply by the deadline stated on the posting (Job posting end date: 05/4/2026).