Drug Product MSAT Engineer- Fill Finish

Regeneron is currently looking for a DP (Drug Product) MSAT (Manufacturing Science and Technology) Engineer to join our Process Science Drug Product Engineering department. This role focuses on lifecycle management & fill finish operations. They will support equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and will be hands-on solving issues following technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The DP MSAT Engineer also provides floor support during operations of off-site manufacturing, reviews process data to ensure operational consistency after the processes are successfully transferred and provides support for investigations.

Essential Duties and Responsibilities:

• Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution.
• Acts as the technical lead, with the support of cross-functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities.
• Tracks and reports project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
• Reviews and approves cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.
• Assists with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations.
• Trends process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations.
• Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
• Supports development of sampling plans for GMP batches related to lot release, stability and characterization.
• Assists in equipment selection, qualification and start up activities.
• Works with Manufacturing to ensure robust procedures are utilized for operation of equipment.
• Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery.
• Maintains required training status on Regeneron specific work instructions and SOPs.
• Travels to contract manufacturers or business partners, as required, up to 25%.

This role might be for you if you:

• Have experience interacting with Contract Manufacturing Organizations.
• Demonstrate technical knowledge in drug product manufacturing, product development and validation.
• Have knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.).
• Possesses strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills required.

To be considered for the DP MSAT Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm and willing to travel. You must have a BS/BA in engineering. For various levels you must have the following:

• Associate DP MSAT Engineer: 0-2 years of relevant experience
• DP MSAT Engineer: 2+ years of relevant experience
• Sr. DP MSAT Engineer: 5+ years of relevant experience

Previous experience working in GMP environment is required. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid le