Regeneron is currently looking for a Manufacturing Sciences & Technology (MSAT) Specialist role within Industrial Operations and Product Supply.

Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies.

The MSAT Specialist provides key technical support for external production of plasmid manufacturing processes including fermentation, purification, and final fill / formulation.

As a MSAT Specialist, a typical day might include the following :

Assess manufacturing requirements and capabilities prior to the execution of new processes at contract manufacturing facilities;

generates facility fit assessments and high-level gap assessments.

Accountable for assisting in generation of and reviewing documentation supporting technology transfer (e.g., manufacturing records, process descriptions, memos, detailed gap assessments, as appropriate).

Compares data across production history and production locations and summarizes findings in memos, reports, and presentations.

Monitors and prioritizes processes and troubleshoots technical difficulties as needed.

Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.

Leads projects and initiatives associated with developing new technical support tools for plasmid manufacture and utilization across multiple API programs.

Collaborates with managers to continuously assess and adjust technical support activities and functions.

Works effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.

Helps to build process knowledge base, controls for technology transfer and knowledge management and lessons learned database;

identifies continuous improvement activities to improve performance.

Assists in developing strategic long term vision for technical support activities impacting tech transfer projects

Other duties as necessary.

This role might be for you if you :

• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
• Ensure all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
• Have experience gathering, trending and analyzing process-generated data; summarizes findings in memos and reports and presentations.
• Are willing and able to travel up to 10-15% travel may be required in support of tech transfer activities.

To be considered for the Manufacturing Sciences & Technology Specialist you must be willing and able to work Monday-Friday, 8am-4 : 30pm and travel occasionally.

You must have a BS / BA in an engineering or related scientific discipline For various levels you must have the following :

• Associate MSAT Specialist : 0-2 years of relevant experience
• MSAT Specialist : 2 years of relevant experience
• Sr. MSAT Specialist : 5 years of relevant experience

Academic or industrial experience with cell, gene, or viral vector therapy delivery modalities, biopharmaceutical process development, or manufacturing process engineering experience is preferred.

Level is determined based on qualifications relevant to the role.

REGNEC

LI-MB1

Last updated : 2024-05-02