Senior Manager Packaging Engineering (Hopewell, NJ)

BeiGene•Hopewell, NJ

1d•Onsite

About The Position

Supporting Product commercialization for BeOne, the Senior Manager Packaging Engineering will have a main focus on our Hopewell, NJ manufacturing site, and responsible for commercial packaging qualification for drug substance, drug product, primary container/closure and final product presentations by: Utilization of standard processes in commercial development and lifecycle management of BeOne products in alignment with the overall manufacturing/packaging capability of BeOne operations at the Hopewell site as well as globally. Serving as the technical packaging lead in cross-functional teams including packaging site, supply chain, commercial, regulatory, finance, clinical, quality as well as across BeOne to commercialize products that create a successful patient experience. Assisting in the development of annual goals and strategic direction for the packaging organization aligning with the company overall strategy. Supporting product launches, tech transfers, and global expansion initiatives at our Hopewell site with packaging expertise. Ensure all packaging systems, equipment and processes comply with global regulatory requirements (e.g., FDA, EMA, etc.).

Requirements

Bachelor’s degree or and 7 years of Engineering experience or Master’s degree and 5 years of Engineering experience
Demonstrated experience leading teams, projects, programs or directing the allocation of resources preferably within the biotech, pharmaceutical, CRO, industry.
Proficient in Microsoft Office applications (Word, Excel, and Outlook), ERP Systems.
Understands comprehensive global pharmaceutical regulatory requirements (e.g. GMP, GDP).

Nice To Haves

Possibly intern supervision

Responsibilities

Manage package development documents (technical drawing, specification, technical assessment, development protocol and report) utilizing the Veeva system.
Develop and execute risk assessment, qualification plan, protocol, and summary report related to component qualification, packaging line testing, and temperature-controlled shipping system.
Support HPW site in commercial launch and after launch efforts, packaging line qualification, pack design and specification, artwork, MBR development, process improvement, and troubleshooting.
Technical support for ongoing packaging activities at the Hopewell site, including process troubleshooting and support for new equipment initiatives.
The pursuit of packaging technologies that will drive innovation and gain efficiency in packaging operations.
Lead commercial packaging engineering activities in market launches and projects to meet predefined timeline and budget.
Manage and execute change controls and deviations related to packaging.
Author regulatory documents in support of product applications or provide regulatory filing and submission support.
Accomplish goals within a team first environment and with respect for all members.
Deliver progress reports and presentations ensuring that management is aware of the current status, progress, and future needs of projects and the organization.
Identify and ensure area of responsibility complies with the most current standards and company policies.