The Manager is accountable for providing technical direction to and oversight of external packaging activities (commercial Biologic and Solid Dose marketed products) for assigned Contract Manufacturing Organization (CMO) relationships with accountability for ensuring product supply to patients. This position will oversee the selection, fundamental design, product transfer, installation, and validation qualification for new packaging equipment associated with Company products. This position manages operational procedures used to produce domestic and global products managed by the US EDCS organization. The Manager will ensure that company standards related to product quality, regulatory compliance, and safety are met in addition to achieving operational excellence and efficiency.
The Manager is responsible for identifying potential packaging operation-related bottlenecks, supply, or quality risks within the current packaging supplier network, as well as strategic opportunities and/or technology improvement initiatives related to product packaging. The Manager develops and recommends action plans to address risk mitigation, contingency considerations, and strategic investment considerations to ensure a robust and stable packaged product supply.
The role of the Manager is a technical role that requires Subject Matter Expert knowledge of pharmaceutical oral solid dose (tablet and capsule) primary packaging into bottles and blisters and secondary packaging with knowledge of labeling, cartoning, and serialization to also include biologic vials and auto injectors. This position requires the ability to independently function with a significant amount of autonomy, personal accountability, ownership, and responsibility for the oversight and management of packaging equipment engineering functions and operations. The Manager brings technical and operational knowledge, sound judgment, responsiveness, and strong communication skills gained through a combination of education, professional training, on-the-job experience, and continued professional development.
Essential Functions
1. Accountable for establishing and maintaining relationships with peers at CMOs, Company network sites, strategic business partners engaged in packaging of Company products.
2. Accountable for the technical oversight and management of packaging equipment projects and initiatives related to primary and secondary packaging of commercial products as well as other pharmaceutical manufacturing steps. Manages Change Control process associated with these changes.
3. Responsible for the successful implementation of packaging equipment changes, site/manufacturer changes, facility improvements and/or equipment enhancements, including cleaning verifications/validations and provide support / troubleshooting during investigations related to packaging or equipment matters.
4. Leads efforts related to packaging CMO identification selection for packaging transfers of existing products, acquisition of new products, and new pipeline products.
5. Accountable for the successful introduction of new product packaging and existing product transfers at CMO’s.
6. Supports packaging project plans assuring integration and achievement of needs from cross- functional stakeholders including Supply Operations, Quality, Global Labeling, Regulatory Affairs are included to achieve desired outcomes on-time and on-budget.
7. Highly knowledgeable in the design and execution of equipment protocols (IQ, OQ, FAT, PQ, etc.) associated with introduction of new equipment or new product introduction to existing production lines equipment.
8. Knowledgeable and experienced with packaging component design with materials such as paperboard, adhesives, inks, glass, plastics, metal, films, labels, and cartons.
9. Working knowledge of line level US serialization requirements. Accountable for compliance of packaging processing operations against registered details (where applicable), industry standards and internal company policies.
10. Applies 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 (preferred) or BS degree with commensurate experience (required)
Technical:
• Minimum of five years of demonstrated successful experience directly managing pharmaceutical contract packaging organizations preferred.
• Demonstrated commitment to continued skills development through on-the-job and/or other continued professional development opportunities also preferred.
• Tangible as well as innate skills of a recognized seasoned, Manager/Engineer as a subject matter expert (SME) with significant pharmaceutical experience.
• Hands-on experience with a variety of packaging equipment types, in a pharma company in engineering and operations support type roles.
• Broad knowledge of relevant FDA, International Council for Harmonization (ICH), and EU guidelines coupled with the ability to interpret, apply guideline principles and regulations to ensure compliance.
• Ability to operate effectively and influence decision-making in a dynamic, multi-cultural, international environment.
• Experience with Microsoft tools/software.
Must Possess:
• Flexible and responsive.
• Ability to communicate effectively and efficiently using verbal, presentation, and written communication skills.
• Ability to build and foster relationships; good interpersonal communication skills.
• Capability to collaborate with diverse teams in demanding environments where resources and time may be limited.
• Aptitude to operate in a clear, decisive manner and reach independent, sound solutions during normal and time-critical situations.
• Advanced influencing skillset to create mutually positive outcomes with CMOs and internal stakeholders alike.
• Strong team player respecting the roles and responsibilities of team members on cross-functional teams.
• Must be self-directed, goal-oriented, quality conscious and team focused; able to work independently with minimal supervision.
• Strong project management skills
• Ability to rapidly see the big picture and assess the impact of data and/or decisions.
• When not traveling, ability to participate in hybrid schedule (2 days onsite at Company Raleigh/3 days working from home).
• Travel (domestic and global) 25% or more may be required.
• Core values in alignment with the Company Values (Integrity, Respect, Professionalism, Quality and Teamwork) together with an intrinsic understanding of Company’s hhc Mission and the need to always think first of the Patient.