Glass Converting Scientist

Regeneron is currently looking for a Staff DP (Drug Product) MSAT (Manufacturing Sciences and Technology) Scientist. This role will focus on thin (tubular) glass manufacturing processes and technology. They will function as subject matter experts (SMEs) for glass-conversions supporting vial and prefilled syringe supplier networks. The role will regularly interact with peers within the network to share learnings and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations. Additionally, they will support industrialization, troubleshooting, and validation of primary packaging components at supplier sites both domestically and internationally.

As a Staff DP MSAT Scientist, a typical day might include the following:

• Interface with the primary container suppliers responsible for tubular cane manufacturing and tubular glass converting.
• Manage critical attribute programs.
• Define and manage cost reduction programs.
• Participate as subject matter expert (SME) for tubular glass forming and tubular glass converting as part of the IOPS Primary Container Counsel.
• Provides technical input to primary container closure selection.
• Propose standardization and business process improvements in order to increase efficiency and timelines.
• Provide regulatory filing support for drug product (IND, BLA, MAA, etc.) as well as support during regulatory inspection of site quality systems.
• Monitor changing regulatory requirements, industry standards, and best practices for formulation and filling as it relates to primary containers. Ensure developments are communicated within the company and appropriately implemented.
• Perform and reviews scientific investigations (EOE & DNF), OOS and OOT IPCs as an SME.
• Perform hand-on experiments and in-process testing to support process development and product industrialization.
• Develop/write/plan and review protocols and activities for manufacturing support and process validation.
• Present findings at group and possibly at interdepartmental meetings.
• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
• Apply statistical process control tools in monitoring the manufacturing process.
• Participate in process and quality risk assessments.
• Support off-site transfer activities as needed.
• Develop validation procedures reflecting best practices in the industry and provide on the floor support and oversight during process validation campaigns.
• Develop strategy and create metrics to measure effectiveness of strategy.
• Continuously drive to improve processes for improved performance.

This role might be for you if you:

• Are willing to travel up to 30%, including domestic or international/ on-site assignments at manufacturing operations worldwide.
• Have excellent process understanding with a background in glass-forming and automation.
• Are knowledgeable of the danner or the vallo tube drawing manufacturing process.
• Enjoy leading a technical team or provide technical leadership in a larger project team to solve problems and drive project work and technical discussions forward.
• Are able to identify roadblocks and anticipate hurdles before they can turn into problems.
• Comfortable presenting– ability to tailor message to the audience.
• Possess strong interpersonal skills – effective at interacting and communicating across varying payroll levels and different functional groups.

To be considered for the Staff DP MSAT Scientist you must have a PhD in a scientific, engineering or related field and 8+ years of related experience.

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