Associate Director, Packaging and Serialization

We are looking for an experienced Associate Director of Packaging and Serialization to manage and lead related packaging and serialization activities including relevant processes and procedures. This individual will report to the Director of Packaging and Serialization.

Responsibilities:

• Provide technical expertise (i.e., Packaging Technology, Package Design, Serialization, Product Security, Packaging Process Development & Optimization, etc.)
• Process Owner and /or the Execution Lead, for one or more processes in packaging and serialization, including but not limited to:
• • New Technology Acquisition
  • New Package Introduction
  • Packaging, Serialization and Artwork
  • Packaging Process Development and Optimization
  • Identification and qualification of alternate sources for packaging components
• Will develop and maintain the technology capability for packaging and serialization, to deliver our services and continuously improve that capability
• Lead, manage and execute all aspects of a project. Accountable for delivery, including but not limited to:
• • Documentation (Packaging Component Specifications, Bill of Materials, Validation/Technical Protocols and Reports, Validation Master Plan, Regulatory Filing Support Documentations, etc.),
  • Right first time documents,
  • Cost of goods productivity improvement for commercial products
  • 100 % filing submissions on time and correct,
  • 100 % Regulatory responses on time and correct, etc.
• Will work with external contract packaging network to create or enhance packaging capabilities to deliver the needed capacity, quality and quantity of packaged goods required by our patients. Will partner with contractors to ensure quality in product packaging and drive elimination of customer complaints relating to packaging
• Must build and maintain strong relationships with key internal and external partner organizations including but not limited to; Component Suppliers, Contract packagers, Product Strategy Leads, Quality Assurance, Procurement, Business Alliance, Research and the Commercial Teams
• Must be able to function independently and influence appropriate stakeholders and recommend scientifically rigorous, risk-management based solutions to complex technical challenges
• Promote continuous improvement in efficiency, quality, and safety through technical development, education and training
• Lead and conduct complex technical investigations
• Authors, reviews, approves regulatory and technical documentation, including but not limited to CMC, SOPs, Validation Master Plans, Validation Protocols and Technical Reports
• Provide technical perspective during internal and external audits, regulatory inspections and due diligence
• Recruit and manage external resources, such as, Consultants and Contractors, as needed to deliver projects
• Interface directly with all Customers and ensure highest level of Customer satisfaction
• To remain current with developments in their respective specialization or practice by actively engaging in and participating in professional organizations

Qualifications:

• Bachelor degree in Packaging Science, Technology or Engineering with 10 or more years relevant experience in managing technical programs such as:
• • Technology acquisition
  • Equipment qualification
  • Process development, scale-up and optimization
  • Package design development
  • Technology transfer
  • Qualification of packaging components from alternate sources
• Ten or more years experience leading highly effective technical teams, developing people and in particular technical capabilities
• Experience in global product launches and the associated CMC regulatory requirements
• Advanced knowledge of cGMP/GLP regulations, ICH, and FDA CMC Guidance Documents is preferred
• Solid organization, problem solving, project-management, decision-making, judgment and team-oriented skills are essential
• Demonstrated ability to simultaneously manage multiple projects of variable complexity
• Strong technical, interpersonal, communication and leadership skills

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.