Senior Drug Product MSAT Engineer

About the role

The Drug Product Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, management of equipment qualification, and process validation activities. They are responsible for solving issues during technology transfer and cGMP start-up for internal or external manufacturing sites. They provide on-the-floor support during operations, review process data to ensure operational consistency, and support investigations.

Responsibilities

• Provides drug product manufacturing process knowledge for new product introduction, technology transfer, process validation, process troubleshooting and issue resolution for biopharmaceutical drug products.
• Tracks and reports project milestones related to raw material/component procurement, equipment readiness, process transfer, manufacturing document creation, etc.
• Reviews and approves cGMP batch documentation (master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities.
• Aids in investigation and root cause determination and CAPA identification and implementation for manufacturing deviations.
• Trends process performance and collaborates with internal and external teams to establish/improve process performance, process capability to ensure process is operating within intended process control strategy.
• Authors technical reports/protocols in support of cGMP activities.
• Supports development of sampling plans for cGMP batches related to process characterization, process qualification, lot release, stability etc.
• Assists in equipment selection, qualification, and start-up activities and works with manufacturing to ensure robust procedures are used for operation of equipment.
• Supports the drafting of regulatory filings and responds to regulatory information requests.

Requirements

• BS in Engineering; chemical engineering or biomedical engineering preferred and 5+ years of relevant experience.

Qualifications

• BS in Engineering; chemical engineering or biomedical engineering preferred and 5+ years of relevant experience.

Skills

• Strong understanding of pharmaceutical manufacturing processes.
• Experience with equipment selection, qualification, and start-up.
• Knowledge of cGMP regulations and standards.
• Ability to troubleshoot and resolve process issues.
• Excellent communication and collaboration skills.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$67,400.00 - $128,700.00 annually

Schedule

Monday-Friday, 8am-4:30pm

25-50% travel domestic & occasionally international