Job DescriptionWHO 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 Quality Control Analyst environmental monitoring will be responsible for collection of environmental samples in clean room areas to support manufacturing operations, sample management activities, and testing of cell therapy in-process, release and stability product samples. He/she will be responsible for reporting of data and writing/revising standard operating procedures (SOPs). He/she may support equipment onboarding and qualification as well as test method qualification in compliance with all applicable quality systems and current cGMPs.HOW YOU
WILL MAKE AN IMPACT
- Perform environmental monitoring of cleanrooms and controlled areas
- Conduct routine and non-routine analyses of samples for in-process, final product, stability, raw materials, and environmental samples.
- Execute sampling and QC Sample Management activities per procedure or written protocols.
- Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
- Write/revise QC specific procedures and protocols for the Cell Therapy manufacturing facility.
- Support implementation of information technologies that support documentation and data management systems.
- May participate in alert/action excursions, investigations, change controls and CAPAs.
*Weekend and Holidays coverage may be required.OUR COMMIMENT
- Certificate in Biotechnology or Bachelor's degree in scientific discipline preferred
- 0-7+ years' experience in manufacturing environment
- Familiarity/experience in a cGMP QC laboratory is desirable
- Ability to adhere to timelines for testing and reporting of data
- Ability to function in a team-oriented environment
- Experience with environmental monitoring working in an Aseptic Processing manufacturing facility is a plus
- Excellent/Effective written and verbal communications skills
- Adhere to scheduled timelines while maintaining flexibility and attention to detail
- Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities
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.