Package Engineering Senior Manager

General Summary:

The Package Engineering Senior Manager is an emerging professional within the department. This role delivers on complex outsourced manufacturing activities in Packaging and is responsible for ensuring positive and effective relationships with all stakeholders. This role will focus primarily on commercializing cell & gene therapy products and preparing pipeline products for launches across a global network.

Key Duties and Responsibilities:

• Represents department on cross-functional CMC sub-teams, with minimal guidance
• Ensures positive and effective relationships with key suppliers of materials, technology, and manufacturing resources
• Manages and designs key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection, testing, and sourcing
• Works effectively with multiple stakeholders including Pharmaceutical Sciences, Manufacturing Sciences & Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, and Marketing to meet project timelines and objectives
• Reviews process performance to identify continuous improvement activities for commercial products
• Supports resolution of quality investigations
• May lead technical transfer and process validation activities; responsible for authoring and reviewing packaging qualification and validation documents.

Knowledge and Skills:

• Experience in one or multiple packaging disciplines including materials and closure systems, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification
• Experience supporting packaging for pharmaceutical products from research, through registration, clinical trials, and commercial launch
• Advanced knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical/biotech environment
• Experience working with internal and external contract manufacturers
• Strong understanding and application of validation processes (IQ/OQ/PQ/PV)
• Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
• Demonstrated ability to manage multiple high-priority projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities
• Ability to navigate a fast-paced, highly-matrixed work environment
• Ability to travel domestic and international (approximately 20%)

Education and Experience:

• Bachelor's Degree in Packaging, Chemical, Mechanical, Material Engineering, or a relevant discipline
• Typically requires 6+ years of experience, or the equivalent combination of advanced education and experience.
• Prior experience with cell & gene therapies, biologics, medical devices/combination products or aseptic fill/finish preferred.