Drug Product MSAT Engineer- Fill Finish

Role Summary

DP MSAT Engineer in Regeneron’s Process Science Drug Product Engineering department focused on lifecycle management and fill finish operations. Will support equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and hands-on issue resolution following technology transfer and cGMP startup. Provides floor support for off-site manufacturing, reviews process data for operational consistency, and supports investigations.

Responsibilities

• Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution.
• Acts as the technical lead, with cross-functional teams, for technology transfer of 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 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 improve process capability within the process control strategy and 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 to ensure on-time delivery from external vendors.
• Maintains required training status on Regeneron-specific work instructions and SOPs.
• Travels to contract manufacturers or business partners, as required, up to 25%.

Qualifications

• This role requires willingness and ability to work Monday-Friday, 8am-4:30pm and travel.
• BS/BA in engineering required.
• 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 a GMP environment required.
• Experience interacting with Contract Manufacturing Organizations is preferred.
• Knowledge of drug product manufacturing, product development and validation; understanding of cGMP, Annex I, and regulatory expectations across multiple health authorities (FDA, EMA, MHRA, etc.)
• Strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills.

Skills

• Technical knowledge in drug product manufacturing, product development and validation
• Process troubleshooting and issue resolution
• Capability to review and approve GMP documentation
• Data review and trend analysis for process performance
• Cross-functional collaboration and technical leadership

Education

• Bachelor‚Äôs degree in engineering or related field

Additional Requirements

• Travel up to 25% for off-site manufacturing support
• On-site work expectations as per company policy