MES Lead

Company: The Lykan Bioscience Hold
Location: Hopkinton
Posted on: May 26, 2023

Job Description:

WHO WE ARE

Lykan Bioscience is a fast-growing and innovative contract development and manufacturing organization (CDMO) focused on cell-based therapies. Cell therapy, one of the most transformative innovations in modern biotechnology, holds enormous potential for treating patients suffering from a variety of diseases. We are on a mission to improve patients' lives by innovating and delivering advanced cell-based therapies.

OUR PASSION

Working at Lykan is not just a job, it's an opportunity to work with a great team with diversified backgrounds and top-tier innovative biotechnology companies to contribute to the development and manufacture of revolutionary, life-saving treatments. Our team's passion for patients uniquely defines us. It's not about what we do; it's about why we do what we do.

THE LYKAN WAY

Here at Lykan, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Innovation, Excellence, Teamwork, Integrity, Trust, and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success, at Lykan we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The MES Lead will be responsible for the design, configuration, implementation, testing, commissioning, qualification, maintenance, and improvement of Electronic Batch Records (eBR) and MES systems.

HOW YOU WILL MAKE AN IMPACT

• Be a site leader in cGMP manufacturing software technology and Lykan standards - develop technical expertise, conduct on-site training, etc.
• Perform design, configuration, and recipe authoring activities of the site's MES application, POMS.
• Support integration, validation, administration, and maintenance activities of the site's MES application.
• Directly support operations with troubleshooting and issue resolution with respect to the MES system.
• Support MES projects to meet deliverables and following up to ensure the desired result has been achieved.
• Provide off-hours manufacturing support as part of an on-call rotation.
• Develop system documents such as standard operating procedures and specifications. Qualifications
  • BS in Engineering, Engineering Technology, or other Technical Degree with 5 years experience working in a regulated GMP environment, preferably in biopharmaceutical manufacturing.
  • Proficient with MS Word, Excel, PowerPoint, and other MS Office suite applications.
  • 3 years MES experience with Emerson Syncade, Werum PAS-X, or POMS.
  • Evidence of teamwork, leadership and initiative taking is strongly desired.
  • Understanding of Warehouse and Inventory management specifically in a GMP facility.
  • Demonstrated proficiency with 3 years experience designing and implementing EBR recipes using GAMP5, S88 and S95 standards.
  • Programming capability in C# and SQL.
    OUR COMMITMENT
    
    All Lykanians embrace the principles of the Lykan Bio culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.
    
    Lykan is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Keywords: The Lykan Bioscience Hold, Worcester , MES Lead, Other , Hopkinton, Massachusetts