At a Glance
- Tasks: Lead IT support for Clinical Manufacturing, ensuring seamless communication and service delivery.
- Company: Join Regeneron, a leader in innovative cell medicine manufacturing.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Collaborative team atmosphere with a focus on continuous improvement.
- Why this job: Make a real impact in a fast-paced, GMP-regulated environment.
- Qualifications: Bachelor's degree in IT or related field; 5-10 years of relevant experience.
The predicted salary is between 60000 - 80000 € per year.
We are seeking a skilled IT professional to serve as the IT Lead for Regeneron's Cell Medicines (RCM) Manufacturing operation to support and maintain all Clinical Manufacturing Equipment and data acquisition/monitoring systems. This role will require strong management skills to effectively manage the support needed from multiple Regeneron Corporate IT services groups and external support vendors, in addition to strong technical skills as the primary On-Site IT SME for the Clinical Manufacturing area. This individual will ensure seamless communication, service delivery, and networking of points of contact across multiple IT groups and the business.
The ideal candidate will have leadership and communication skills, experience in a GMP (Good Manufacturing Practices) environment, and the ability to troubleshoot on-site IT issues related to all Manufacturing and QC equipment and facilities IT systems.
As an IT GxP Manufacturing Lead, a typical day may include:
- Serve as the primary point of contact between RCM and Corporate IT, coordinating support across internal groups and external vendors.
- Align IT services with RCM’s needs by facilitating clear stakeholder communication on requirements, timelines, and deliverables.
- Lead planning and execution of IT projects and initiatives within a GMP environment, ensuring effective cross-team coordination.
- Provide regular operational and project status updates, metrics, and risk/issue reports to leadership.
- Manage and direct contracted IT personnel and oversee vendor performance for service delivery.
- Troubleshoot and resolve on-site IT issues for manufacturing, QC equipment, and facilities systems (hardware/software), ensuring rapid restoration.
- Ensure high availability and resilience of critical systems through monitoring, preventive maintenance, backups/archiving, and recovery readiness.
- Develop and maintain GxP documentation, including specifications, test protocols, validation/CSV records, and system administration SOPs.
- Support integration of equipment and systems with LIMS and other enterprise platforms in coordination with Corporate IT; supervise EMS for compliance and reliability.
- Ensure GMP/regulatory compliance by partnering with QA, managing IT tasks in CMMS, maintaining audit readiness, and driving continuous improvement of workflows and support processes.
This role could be for you if you:
- Have strong management and leadership abilities.
- Possess excellent written and verbal communication skills.
- Can collaborate effectively with cross-functional teams.
- Have a proven track record of collaborating with corporate IT teams.
- Can adapt to a fast-paced, multifaceted work environment.
To be considered for this role, you must meet the following:
- Bachelor’s degree in information technology, Computer Science, or a related field.
- 5 – 10 years' demonstrated ability in an IT role, preferably within a GMP-regulated environment.
- Proficiency in troubleshooting all IT aspects of manufacturing/QC equipment and other data collection/monitoring systems (e.g. EMS).
- Familiarity with GMP requirements and IT compliance standards.
IT Lead, Manufacturing GxP employer: Regeneron
Regeneron is an exceptional employer, offering a dynamic work environment that fosters collaboration and innovation in the field of IT within a GMP-regulated manufacturing setting. Employees benefit from comprehensive professional development opportunities, a strong commitment to regulatory compliance, and a culture that values diversity and inclusion. Working on-site at Regeneron's Cell Medicines Manufacturing operation not only allows for impactful contributions to cutting-edge healthcare solutions but also ensures a supportive atmosphere where your skills and leadership can thrive.
StudySmarter Expert Advice🤫
We think this is how you could land IT Lead, Manufacturing GxP
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already at Regeneron. A friendly chat can open doors and give you insider info on what they're really looking for.
✨Tip Number 2
Prepare for the interview by brushing up on your technical skills and leadership examples. Be ready to share how you've tackled IT challenges in a GMP environment – they’ll want to hear about your hands-on experience!
✨Tip Number 3
Showcase your communication skills! During interviews, make sure to demonstrate how you can effectively liaise between teams. Use specific examples of how you've facilitated clear communication in past roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're serious about joining the team at Regeneron.
We think you need these skills to ace IT Lead, Manufacturing GxP
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the IT Lead role. Highlight your experience in GMP environments and any relevant technical skills. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the role. Share specific examples of your leadership and communication skills, especially in cross-functional teams.
Showcase Your Technical Skills:Don’t forget to highlight your troubleshooting abilities and familiarity with manufacturing/QC equipment. We’re keen on seeing how you can manage IT issues effectively in a fast-paced environment.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Regeneron
✨Know Your GxP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) and how they relate to IT. Be ready to discuss specific examples of how you've ensured compliance in past roles, especially in a manufacturing environment.
✨Showcase Your Leadership Skills
Prepare to share instances where you've successfully managed teams or projects. Highlight your ability to coordinate between different IT groups and external vendors, as this will be crucial for the role.
✨Communicate Clearly and Effectively
Practice articulating complex IT concepts in simple terms. Since you'll be liaising with various stakeholders, demonstrating your communication skills during the interview will set you apart.
✨Be Ready to Troubleshoot
Expect technical questions that test your troubleshooting skills. Think of scenarios where you've resolved IT issues in a manufacturing setting and be prepared to walk the interviewer through your thought process.
