Manager Quality Control

Regeneron Pharmaceuticals • Rensselaer, IN

2d • Onsite

About The Position

Regeneron is looking for a hands-on people leader in Quality Control – Technical Resources to perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development. A typical day in this position may include: Perform assay development and validation for QC Chemistry group. Review new test procedures and assays. Standardize documentation (SOP’s, protocols, reports) and drive process improvements and a safety culture. May evaluate and bring in new methodologies/techniques when needed. Facilitate assay transfer from R&D to business partners. Organize analytical assay transfer internally and externally. Participate in technical troubleshooting and problem investigation. Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance. Perform personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations. This position may be for you if: You have in-depth knowledge with HPLC based assays. You have previous experience training and mentoring a team. You have experience with LC-MS, dissolution testing, stability studies or biologics analytics. You are proficient with chromatography data systems. You have excellent communication, stakeholder management, and change leadership skills. You can prioritize work, allocate resources, and optimize scheduling to meet turnaround times.

Requirements

• BS/BA in Life Sciences, or related field
• 7 years of experience working in a GMP lab including a minimum 2 years of management experience.
• In-depth knowledge with HPLC based assays.
• Previous experience training and mentoring a team.
• Proficient with chromatography data systems.
• Excellent communication, stakeholder management, and change leadership skills.
• Prioritize work, allocate resources, and optimize scheduling to meet turnaround times.

Nice To Haves

• Advanced degree preferred
• Experience with LC-MS, dissolution testing, stability studies or biologics analytics.

Responsibilities

• Perform assay development and validation for QC Chemistry group.
• Review new test procedures and assays.
• Standardize documentation (SOP’s, protocols, reports) and drive process improvements and a safety culture.
• May evaluate and bring in new methodologies/techniques when needed.
• Facilitate assay transfer from R&D to business partners.
• Organize analytical assay transfer internally and externally.
• Participate in technical troubleshooting and problem investigation.
• Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
• Perform personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations.

Benefits

• 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
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees