Technical Lead Container Closure Systems (All Genders) - Fulltime, Permanent

Role Summary

ABBVie's Product Development Science & Technology organization seeks a Technical Lead for Container Closure Systems (CCS) to drive development and lifecycle management of primary packaging components for sterile dosage forms. The role requires leadership across cross-functional teams, collaboration with manufacturing, quality, procurement, development, device teams and external partners to ensure successful development and commercialization of drug products. You will work with global multi-functional teams, serve as a technical lead on projects, and contribute CCS insights from early development through product launch, technical commercial support, and lifecycle management.

Responsibilities

• Deliver technical expertise in the development of container closure systems, including vials, prefilled syringes, and prefilled cartridges, using cutting-edge methodologies to analyze protection, safety, compatibility, and performance attributes
• Provide technical leadership for primary packaging selection and qualification for sterile dosage forms, develop specifications for packaging components, manage internal/external tech transfer, and lifecycle management for commercial products
• Partner with device development teams to ensure system-level requirements for combination products are developed, verified, and validated in alignment with design controls
• Support continuity of supply for marketed products and ensure technical performance, processability, and safety of primary packaging components and systems
• Lead CCS-related technical impact assessments for investigations, complaints, and change control

Qualifications

• M.Sc. or Diploma (and 12+ years) or PhD degree (and 6+ years) in Parenteral manufacturing, Parenteral process development, Container closure and combination product development, Product Quality, Analytical, Material Sciences, or related fields
• Expert knowledge and practical experience in container closure systems, including CCS materials, E&L concepts, functional CCS characterization, and Container Closure Integrity testing
• Profound knowledge of quality and regulatory requirements for container closure systems for parenteral pharmaceutical and biopharmaceutical products, primary packaging materials and drug/device combinations
• Practical experience and strong knowledge of Parenteral Fill finish processes; solid understanding of pharmaceutical development in a cGMP environment
• Strong leadership and communication skills, demonstrated through successful establishment and management of cross-functional teams in a manufacturing setting
• Strong analytical and problem solving skills; able to work independently and respond to changing priorities and short lead times for multiple tasks