Director, Sterile Product and MDCP Packaging

Job Description

Reporting to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for packaging development activities from packaging design concept through launch, strategic management of the sterile development portfolio, and delivering on organizational unit priorities.   The Director will be responsible for new product packaging development for vaccine and biologic dosage form products, including Medical Device and Combination Products (MDCPs) in the human health portfolio.

The successful candidate will have organizational, technical, and project leadership experience commensurate with leading a technical organization responsible for development and commercialization of a portfolio of products.  The Director will manage a team of scientists and engineers who are responsible for delivering robust packaging systems for cell banks, drug substance, drug product, and finished goods.  Development activities include the design, characterization, qualification, and tech transfer of robust packaging systems to commercial sites, as well as packaging process co-development with commercial device assembly and packaging sites.  Additionally, the successful candidate will have demonstrated understanding and experience of unique requirements of packaging system development of Medical Device and Combination Products, including pre-filled syringes and autoinjectors. 

This Director will be responsible for the professional development of team members, as well as driving transformation within the broader Packaging Commercialization organization, overseeing budget and capability investments and the successful completion of projects, ensuring strong scientific excellence and strategic decision making. The candidate will be expected to build inclusive, collaborative partnerships with internal and external stakeholders such as drug substance, drug product, device, analytical, regulatory, project leaders, manufacturing sites, and other key stakeholders in CMC development and packaging operations.  The successful candidate will model ownership and define informed strategies based on analysis of inputs, outcomes, risks, and enterprise-wide prioritization.

Primary Responsibilities include:

• Lead a sterile product group, accountable for people and operations, including managing a sterile portfolio budget, business process optimization, and employee development.
• Provide technical direction and oversight of engineering of sterile product packaging systems, including pre-filled syringes and autoinjector combination products
• In collaboration with other sterile and non-sterile portfolio group leads, introduce and improve standard work processes supporting packaging development core deliverables.  
• Provide leadership in areas of problem solving, risk identification and mitigation, and scenario planning in support of teams bringing new products to market.  
• Work in collaboration with other development functions including Drug Product, Device, Analytical, and Drug Substance to ensure thorough science and engineering are underpinning deliverables
• Work in collaboration with packaging site technical and operations groups to optimize processes for technical and knowledge transfer of new products to the device assembly and packaging sites.
• Build talent and provide proactive support in training and coaching to team members
• Remain informed of current quality and regulatory requirements and industry trends as described in worldwide regulations and industry standards
• Maintain an active network of practitioners and resources in relevant fields of expertise
• Demonstrate financial stewardship in all areas of responsibility

Minimum Education Requirement and Experience:

• Bachelor of Science (BS) Degree in life sciences or equivalent with at least fifteen (15) years of relevant experience. OR
• Master of Science (MS) Degree in life sciences or equivalent with ten (10) years of relevant experience. OR
• PhD in life sciences or equivalent with seven (7) years relevant experience.

Required Skills and Experience:

• Demonstrated ability to manage teams
• Advanced understanding of Medical Device and Combination Products (e.g. pre-filled syringes, autoinjectors)
• Strong strategic and business acumen
• Ability to provide clear, unambiguous expectations and priorities for direct reports