Packaging Technical Lead; Associate Director

Position: Packaging Technical Lead (Associate Director)
** Job Description*
* 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.

The Associate Director will be accountable for the definition and execution of overall packaging strategies that meet global network needs. Responsibilities include ensuring packaging system designs are robust, packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. They will ensure activities supporting these program deliverables are executed with technical rigor and drive risk understanding and reduction prior to product launch.

The Packaging Technical lead will be accountable for technical risk assessments, packaging specifications, and qualification activities, while ensuring compliance with all regulatory standards and sustainability goals. Individuals in this role will lead with ownership and accountability for representing, communicating, and balancing the interests of stakeholders. They will have an ability to effectively drive the right risk posture that balances technical probability, cost and resources, and trade-offs across various groups.

The role requires strong technical skills, problem-solving abilities, and the capacity to navigate complex situations in a fast-paced environment, all while aligning packaging with product and patient needs.

The successful candidate will bring expertise in the design of primary, secondary and tertiary pharmaceutical packaging systems, including blow-fill-seal technologies. They will collaborate with stakeholders across the end-to-end continuum of CMC areas and require both an understanding of packaging components and processes, as well as prior experience developing and commercializing new products on cross-functional teams.

** Responsibilities*
* + 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.

** Qualifications*
* _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)…