Sr. Manager, Pharmaceutical Packaging Operations – EU
Location: Maidenhead, England
Department: Manufacturing Operations EU
Quality is our primary guiding principle. It is the foundation on which all functions and activities are performed. Excellence in the management of Quality is fundamental and the foremost aspect upon which the Pharmaceutical Operations team are judged by our patients, caregivers, partners, colleagues, and regulatory bodies. Our commitment is to go beyond compliance and operate effective development, operations and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of and their families living with serious rare diseases. The Zogenix Technical Operations & Product Supply (TOPS) group is responsible for integrating and executing all Chemistry, Manufacturing, and Controls activities as well as operations functions such as engineering, manufacturing, analysis, supply, procurement, operational excellence, capacity management, distribution, wholesaling and logistics for all products.
The Senior Manager, Pharmaceutical Packaging will drive the Zogenix process and product expertise to ensure that global pharmaceutical packaging processes and equipment consistently deliver Zogenix products to the clinic and market according to the approved production plan, quality requirements, and cost targets. This will be accomplished by acting as the technical and process subject matter expert for all packaging operations in addition to holding all the necessary product knowledge as it relates to manufacturing.
The role will also cover the areas of packaging design, finished product configuration (commercial and clinical) and artwork management The position will be responsible for leading investigations and closing out discrepancies to improve manufacturing processes and equipment located at all Contract Manufacturing Partners (CMPs) and any Zogenix-managed component and raw material providers upstream of those CMPs in a manner consistent with lean operations and minimum total operating costs.
The role will have responsibilities for supporting new product introductions from a packaging and artwork perspective, working cross functionally and with suppliers to agree user requirement specifications and generating designs that meet the product, commercial and end-user requirements. The management of new packaging SKUs including artwork design and packaging Regulatory aspects by market, along with the management of artwork changes and revisions for existing SKUs, will be a key part of the role. In addition, the scope of the position will include identifying and implementing improvements to packaging operations, both from a technical and organizational / operational excellence perspective. All work will be done in compliance with Zogenix’ and the applicable CMO’s quality systems, including change control, document control and training, always in coordination with both Zogenix and the contract manufacturer’s Quality and Operations functions.
The position requires being the product subject matter expert following development, through process validation into commercial phase. This requires close interactions and participation during product development phases, with specific responsibilities as the manufacturing and pharmaceutical engineering representative.
Essential Duties and responsibilities
Packaging Duties and Responsibilities
- Responsible for developing packaging processes, including artwork and packaging component development
- Lead investigations of, and resolutions to specific manufacturing or production quality and throughput issues with contract manufacturers, equipment, component and/or raw material suppliers
- Provide technical expertise regarding pharmaceutical packaging manufacturing equipment, processes and components.
- Set up and manage component artwork processes, and hold the requisite knowledge to ensure compliance with current artwork and labeling regulations in all Zogenix markets
- Implement serialization processes and systems to ensure commercial packaging and labelling comply with local market requirements
- Work with cross functional groups to identify requirements for commercial and clinical packaging configurations and presentations, providing the Zogenix expertise for packaging design and optimization for manufacturing
- Implement packaging solutions (structural and printed components)
- Work with 3rd part artwork design and artwork management providers and CMOs to generate, update and maintain artwork files for multimarket SKUs
- Other duties as assigned.
Manufacturing duties and Responsibilities
- Carry out Person-in-the-Plant duties and provide manufacturing oversight during process execution
- Develop optimization plans for the manufacturing equipment, processes and operating procedures through careful and scientific analysis
- Support improvements in process robustness, efficiency, yield, and manufacturing costs, working in close collaboration with the relevant CMP and component supplier representatives and internal Zogenix functions.
- Work with the CMO to ensure a robust and reproducible manufacturing processes, including the development and supervision of effective continuous improvement processes
- Analyze manufacturing data, identify and assess potential risks and develop/implement risk mitigation programs
- Through routine contact with manufacturing partners and internal cross-functional teams, coordinate activities required, using project management techniques and skills, to ensure all operational activities are maintained to agreed timelines
- Draft, review and approve master manufacturing templates and documentation including Standard Operating Procedures, Master Batch Manufacturing Records, Training Records and Specifications.
- Recommend enhancements to systems and processes within the pharmaceutical manufacturing operation, associated with proposed product changes
- Fulfil the role of technical subject matter expert for the product and associated manufacturing processes
- Provide technical input into validation strategy and execution
- Provide the manufacturing expertise and input into regulatory filings, and be the technical representative during Regulatory and internal audits
- Lead internal teams as required to implement improvements and execute projects to support product commercialization
- Other duties as assigned.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in engineering or other Technical field. Master’s degree preferred.
- 8+ years of experience in Pharmaceutical manufacturing/packaging environment required.
- Significant experience working with third party vendors, contractors and contract manufacturers (packaging, artwork, printing, component suppliers) in a role requiring relationship management.
- Must have experience influencing partner organizations to achieve positive outcomes without reporting or significant economic leverage
- Experience with validation of pharmaceutical equipment and processes, and familiarity with cGMP and Regulatory aspects of pharmaceutical manufacturing
KNOWLEDGE SKILLS AND ABILITIES
- Must have a thorough knowledge of regulatory guidelines for packaging and labelling, cGMP’s, ISO standards and pharmaceutical packaging best practices and a solid understanding of technical aspects of packaging equipment and component supply processes. Should be familiar with serialization implementation and guidelines in multiple markets
- Training/Certification in lean manufacturing and in leading and closing out investigations, deviations and CAPA activities
- Project management skills and experience managing outside contractors/suppliers is required
- Strong electrical & mechanical troubleshooting skills and knowledge
- Must be flexible and adaptable in constantly changing environments. Able to lead and move projects forward with initiative, being comfortable leveraging experience to create clear plans with minimum direction.
- Must have a bias for action and display a sense of urgency. Must possess exemplary skills in leadership, communication, and project management while maintaining extremely high quality and efficiency standards
- Must be willing and able to make sound business decisions and act on them with urgency and for the benefit of the Company
- Excellent communication skills. Willing and able to develop and nurture productive business relationships with colleagues, partners, suppliers, contractors, leaders and subordinates
- Excellent interpersonal skills. Demonstrably able to influence positive outcome without direct reporting authority
- Able to quickly and accurately evaluate internal and external operations, recommend optimal decision paths based on those evaluations and lead the organization to successful delivery of business objectives
- Willing and able to travel domestically and internationally, up to 50% of the time