Associate Director, Manufacturing Operations

Location: Emeryville, CA
Department: Manufacturing Operations

POSITION SUMMARY

Quality is the primary guiding principle at Zogenix. 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 quality, 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 patients and their families living with serious rare diseases.

The primary role of Associate Director, Manufacturing Operations is to provide Zogenix manufacturing leadership and expertise across global manufacturing operations.  This will require both a foundation of technical process and product expertise, in addition to a strong management and strategic focus, to ensure that all manufacturing operations deliver Zogenix products to the clinic and to market according to the approved production plans, quality requirements, and cost targets. 

A key aspect to this position will be management of outsourced manufacturing activities, with the objective of ensuring reliable, robust processes and routinely achieving excellent service levels.  The person fulfilling this role will represent manufacturing within Zogenix, as the technical and process subject matter expert for API and drug product operations, including product knowledge as it relates to manufacturing.  All work will be done in compliance with Zogenix and CMO’s systems and procedures, including change control, document control and training, always in coordination with both Zogenix and the contract manufacturer’s Quality and Operations functions. The position will entail being the manufacturing subject matter expert for technical transfer projects, including second source introductions. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Overall responsibility for the manufacturing performance of Zogenix contracted manufacturing partners, including long-term planning and strategic initiatives
  • 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
  • Lead internal teams as required to implement improvements and execute projects to support product commercialization
  • Provide technical and manufacturing input to key supply chain enhancement projects, including technical transfers and second source setup.
  • Support new product introductions in early stage manufacturing process development, supplier selection and support through validation phases
  • 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 manufacturing equipment, processes, and components
  • Carry out Person-in-the-Plant duties and provide manufacturing oversight during process execution
  • Through careful and scientific analysis, develop optimization plans for the manufacturing equipment, processes, and operating procedures
  • 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 detailed process data for drug product and API manufacturing processes, identify and assess potential risks and develop/implement risk mitigation programs
  • 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
  • Other duties as assigned

EDUCATION AND EXPERIENCE

  • Bachelors degree in Engineering or other Technical field.
  • Requires 8-10 years in Pharmaceutical manufacturing/processing plant environment
  • Must have a thorough knowledge of cGMP’s, ISO guidelines and pharmaceutical/biotechnology/device industry best practices and a solid understanding of technical and operations aspects of aseptic processes, automated assembly processes, automation and control systems, container closure component supply chains and packaging equipment. Must be well versed in CMC regulatory guidelines
  • Significant experience working with third party vendors, contractors, and contract manufacturers (API and drug product) in a role requiring relationship management. Must have experience influencing partner organizations to achieve positive outcomes without reporting or significant economic leverage
  • The candidate must have experience with validation of pharmaceutical equipment and processes, and familiarity with cGMP and Regulatory aspects of pharmaceutical manufacturing
  • Training/Certification in lean manufacturing and in leading and closing out investigations, deviations and CAPA activities
  • Project management skills and specific experience managing outside contractors/suppliers is also required
  • Strong electrical & mechanical troubleshooting skills and knowledge

KNOWLEDGE SKILLS AND ABILITIES

  • Must be flexible and adaptable in constantly changing environments. Able to lead and move projects forward with environmental and organizational ambiguity and without clear and concrete 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 60% of the time