Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
Provide subject matter expertise and ensure scientific rigor, technical problem solving, and execution excellence across the portfolio.
Provide strategic leadership and direction for the development of standard work to characterize the real-world distribution environment.
Ensure thorough engineering and distribution packaging science is applied to deliverables for new product introductions and technology transfers across the network.
Deliver the development, design, construction, qualification/validation, and/or initial operation of complex tertiary packaging components and processes.
Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
Collaborate with cross-functional teams and stakeholders to ensure that all platforms meet safety, efficacy, quality, and robust supply standards.
Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support.
Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of COE support.
Remain informed of current Good Manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) and requirements and industry trends.
Requirements
Bachelor of Science (BS) in packaging, mechanical, chemical, biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years of required experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR Master of Science (MS) in packaging, mechanical, chemical, biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years of required experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR PhD in packaging, mechanical, chemical, biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years of required experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields
Subject matter expertise in distribution technologies (e.g. cold-chain, thermal protection systems, temperature profiles, monitoring technologies, shock, and vibration), processes and operations across internal and external partners and third-party logistics providers.
Subject matter expertise in development and qualification of package design and/or distribution/transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products.
Demonstrated experience in a leadership role, managing technical team in support of packaging or distribution operations, or related functions.
Strong problem-solving and decision-making skills with an ability to interrogate the science, identify true requirements, and detect critical flaws.
In-depth knowledge of global regulatory requirements for distribution including good distribution practices.
Able to guide key activities including development of standard work, investigations, and problem solving.
Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support.
Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.
Tech Stack
Assembly
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)