Packaging Technical Lead; Associate Director

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. We are seeking an Associate Director, Packaging, to join our team and lead the definition and execution of overall packaging strategies that meet global network needs.

• Ensure packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs.
• Drive risk understanding and reduction prior to product launch.
• Conduct technical risk assessments, develop packaging specifications, and oversee qualification activities.
• Ensure compliance with all regulatory standards and sustainability goals.
• Represent, communicate, and balance the interests of stakeholders.
• Drive the right risk posture that balances technical probability, cost, resources, and trade-offs across various groups.
• Collaborate with stakeholders across the end-to-end continuum of CMC areas.
• Develop and commercialize new products on cross-functional teams.

Required

• Bachelor of Science (B.S.) in Packaging Engineering, Packaging Science, Mechanical Engineering, or similar field with ten (10) years of relevant pharmaceutical development experience;
  OR MS/PhD with 8 years
• Demonstrated understanding of pharmaceutical development process and ability to design, develop, and test primary and secondary packaging components.
• Demonstrated understanding of the use of Risk Assessment tools.
• Ability to work both independently and as part of a larger team.
• Experience in leading cross-functional groups both internally and externally.
• Experience with blow-fill-seal technologies for sterile pharmaceutical packaging systems.
• Project management experience and ability to provide technical leadership for complex projects while managing multiple projects in a fast-paced environment.
• Excellent technical written and oral communication skills that support presentation of information clearly and concisely for all levels of the organization.
• Knowledge of current US and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging.
• Strong interpersonal skills and the ability to influence senior leaders.
• Ability to manage complex programs and support multiple activities/projects.
• Willingness to grow and learn all areas of Pharmaceutical new product development.

Preferred

• Medical Device and Combination Product Packaging development experience.
• Quality Risk Management, Risk-Based Decision Making, and Quality by Design (QbD) experience.
• Experience in defining standard work processes and documents.
• Experience specifying, processing, and characterizing packaging materials including rigid and flexible barriers, pulp/paperboard, and recyclables.

Ability to Coordinate, Ability to Coordinate, Change Management, Collaborative Leadership, Combination Products, Competency Management, Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Global Coordination, Good Manufacturing Practices (GMP), Group Processes, ISO Compliance, Legal Compliance, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Procedure Writing, Process Definition, Process Optimization, Project Leadership, Project Management Leadership, Project Team Management {+ 10 more}

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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: EEOC Know Your Rights EEOC GINA Supplement.

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