Director, Assembly and Packaging Platform Technical Leadership

Responsibilities

Lead, mentor, and develop a team of technical staff, fostering a culture of 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 activities, including risk assessment, risk mitigation, and risk communication strategies. Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support and platform stewardship.

Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities. Provide strategic leadership and direction for technical support for the platform stewardship team, including management of ongoing changes and tech transfers. Provide technical guidance to lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.

Required:

Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience; OR PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience.

Subject matter expertise in medical device and combination product commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply. Demonstrated experience in a leadership role, managing technical teams supporting packaging as well as combination product assembly & packaging. Strong problem solving and decision making skills with an ability to interrogate the science, identify true requirements, and detect critical flaws.

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. Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship. Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.

• Accountability
• 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

Salary range: $ - $.

Benefits include medical, dental, vision, healthcare and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC website.