Sr. Mgr., Contract Packaging (Hybrid)

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.

The Sr. Manager of Contract Packaging is responsible for providing strategic leadership and comprehensive oversight of external packaging activities for commercial Biologic and Solid Dose marketed products. This role manages technical relationships with Contract Manufacturing Organizations (CMOs) to ensure a reliable supply of products to patients. The Sr. Manager will lead the selection, design, transfer, installation, and validation of new packaging equipment for Eisai products, ensuring compliance with Eisai standards for product quality, regulatory adherence, and safety, while driving operational excellence and efficiency.

Key responsibilities include identifying and mitigating potential bottlenecks, supply chain disruptions, and quality risks within the packaging supplier network. The Sr. Manager will also spearhead strategic initiatives and technological advancements to enhance product packaging. They will develop and implement action plans for risk mitigation, contingency planning, and strategic investments to ensure a robust and stable supply of packaged products.

This senior technical role demands Subject Matter Expert knowledge in pharmaceutical packaging, including primary packaging of oral solid doses (tablets and capsules) into bottles and blisters, and secondary packaging involving labeling, cartoning, and serialization, as well as biologic vials and auto injectors. The Sr. Manager must operate with a high degree of autonomy, demonstrating personal accountability and ownership in managing packaging equipment engineering functions and operations. 

They will leverage their extensive technical and operational expertise, sound judgment, and strong communication skills, acquired through advanced education, professional training, and significant industry experience.

Essential Functions

• Establish and maintain strategic relationships with peers at CMOs, Eisai network sites, and key business partners involved in the packaging of Eisai products.

• Provide strategic oversight and management of packaging equipment projects and initiatives related to primary and secondary packaging of commercial products, as well as other pharmaceutical manufacturing processes. Oversee the Change Control process for these changes.

• Ensure successful implementation of packaging equipment changes, site/manufacturer transitions, facility improvements, and equipment enhancements, including cleaning verifications/validations. Provide support and troubleshooting during investigations related to packaging or equipment issues.

• Lead efforts in identifying and selecting CMOs for packaging transfers of existing products, acquisition of new products, and new pipeline products.

• Ensure the successful introduction of new product packaging and the transfer of existing products at CMOs.

• Support packaging project plans, ensuring the integration and achievement of requirements from cross-functional stakeholders, including Supply Operations, Quality, Global Labeling, and Regulatory Affairs, to achieve desired outcomes on time and within budget.

• Design and execute equipment protocols (IQ, OQ, FAT, PQ, etc.) associated with the introduction of new equipment or new product introductions to existing production lines.

• Design packaging components using materials such as paperboard, adhesives, inks, glass, plastics, metal, films, labels, and cartons.

• Ensure compliance with US serialization requirements and packaging processing operations against registered details (where applicable), industry standards, and internal company policies.

• Apply extensive knowledge and experience as a Subject Matter Expert (SME) across and beyond the boundaries of packaging equipment.

Requirements

Education:

Bachelor of Science in a relevant engineering discipline (e.g., Mechanical, Electrical, Industrial),

or a related field (required)

Technical:

• 8+ years managing pharmaceutical contract packaging at multiple CMO sites in the US and Europe.

• Commitment to ongoing professional development.

• Recognized SME with significant pharmaceutical experience.

• Hands-on experience with various packaging equipment in engineering and operations.

• Knowledge of FDA, International Council for Harmonization (ICH), and EU guidelines; ability to ensure compliance.

• Effective in a dynamic, multi-cultural, international environment.

• Proficient with Microsoft tools/software.

Must Possess:

• Flexibility and responsiveness.
• Strong verbal, presentation, and written communication skills.
• Ability to build relationships and collaborate with diverse teams.
• Decisive problem-solving in normal and critical situations.
• Adaptability to changing priorities in a fast-paced environment.
• ·Advanced influencing skills for positive outcomes with CMOs and stakeholders.
• Team player with respect for cross-functional roles.
• Self-directed, goal-oriented, and quality-conscious.
• Strong project management skills; ability to manage multiple projects and meet deadlines.
• Ability to see the big picture and assess data impact.
• Hybrid work capability (2 days onsite, 3 days remote); 25%+ travel required (domestic and global).
• Alignment with Eisai Values (Integrity, Respect, Professionalism, Quality, Teamwork) and Eisai’s hhc Mission, prioritizing the Patient.

#LI – SC1

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Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.  Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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