Process Specialist - Manufacturing

About the role

Join our IOPS team and provide technical support across our manufacturing processes. Resolve process challenges, support manufacturing personnel, and drive continuous improvement.

Responsibilities

• Liaise with process science and technology transfer teams on the transfer and startup of manufacturing processes
• Provide technical input to resolve process problems on and off the production floor
• Support manufacturing personnel in building technical knowledge of critical process steps
• Write and review SOPs and other controlled documents
• Modify process method files through the quality system in alignment with change control requirements
• Support CAPA implementation for process-related improvements and contribute to investigations into process variances in accordance with site procedures
• Partner cross-functionally with Maintenance, Process Sciences, Engineering, Facilities, Process Development, Regulatory, Quality Assurance, and Quality Control to resolve process issues and implement improvements
• Represent Manufacturing during regulatory and client audits
• Uphold the highest safety standards and support safety improvements requiring technical input

Requirements

• BS in Life Sciences or a related field
• 02 years of relevant cGMP manufacturing, engineering, or scientific experience for Associate Specialist
• 2+ years of relevant cGMP manufacturing, engineering, or scientific experience for Specialist
• 5+ years of relevant cGMP manufacturing, engineering, or scientific experience for Senior Specialist

Qualifications

• Familiarity with drug substance or drug product manufacturing processes preferred
• Experience in a cGMP manufacturing environment

Skills

• Technical expertise in manufacturing processes
• Strong problem-solving and communication skills
• Collaborative mindset

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitnes centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

$62,355.00 - $128,700.00 annually

Schedule

Monday - Friday 8am - 4:30pm