Drug Product MSAT Engineer- Fill Finish

Role Summary

DP MSAT Engineer – Drug Product focuses on lifecycle management and fill finish operations within the Process Science Drug Product Engineering department. The role supports equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and hands-on issue resolution following technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations and provides floor support during off-site manufacturing, reviews process data for operational consistency after transfer, 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, and manufacturing document creation.
• 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 establish/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 for operation of equipment.
• Partners with Strategic Sourcing/Procurement to specify technical requirements for raw materials, components, equipment and services to ensure on-time delivery.
• Maintains required training status on Regeneron work instructions and SOPs.
• Travels to contract manufacturers or business partners, as required, up to 25%.

Qualifications

• Required: Experience interacting with Contract Manufacturing Organizations; technical knowledge in drug product manufacturing, product development and validation; knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities; strong project management, interpersonal, cross-cultural, communication, negotiation and problem-solving skills.
• Preferred: Prior GMP experience; ability to operate in a multidisciplinary, global team environment.

Education

• BS/BA in engineering or related field.