Director, Quality Control

Company: Lykan Bioscience
Location: Hopkinton
Posted on: June 22, 2022

Job Description:

WHO WE ARELykan 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 PASSIONWorking 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 WAYHere 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 Director Quality Control is responsible for leading the Quality Control function at Lykan Bioscience. This position will provide leadership and guidance for the Quality Control team (Microbiology, Analytical and Technical Services) and work cross functionally to identify and mitigate potential quality risks. HOW YOU WILL MAKE AN IMPACT

• Partners with the Site Quality Head and Leadership Team in executing the strategic goals of the company.
• Drives continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals.
• Develops and executes the QC strategy for the site. Ensures quality and delivery meets or exceeds internal stakeholder and customer expectations.
• Oversees raw materials testing, in-process and finished product testing, environmental monitoring and microbiology, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management and QC document management.
• Works closely with Program Management, cross functional project teams and customers to support technical transfer and product management throughout the product lifecycle.
• Attends Site Quality Council and other meetings as needed, e.g. Change Control Committee, Deviation Review Board, CAPA Board
• Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues
• Builds and maintains expertise in the QC organization, ensuring that the QC organization supports site operations through ongoing development of staff.
• Supports Regulatory and Customer Audits as needed.
• Manage the QC budget process.
• Performs other duties as assigned.QUALIFICATIONS
  • Bachelor degree and/or Advanced Graduate degree (MS/PhD) with 10 plus years of experience
  • Preferred area of study: Microbiology, Biochemistry or equivalent Science Field. Prior experience with rapid methods (BacT, qPCR, etc) a plus
  • Extensive experience in a GMP/Professional environment, preferably in cell therapy.
  • Preferred experience in the pharmaceutical industry.
  • Experienced people leader with demonstrated ability to mentor and coach both experienced and inexperienced staff
  • Prior direct supervisory/manager experience, experience growing and leading a QC team.
  • Experience with implementation of laboratory computer systems a plus
  • Ability to prioritize and plan QC support for multiple on-going projects
  • Excellent communications skills both written and verbal format.
  • Team player with ability to maintain positive attitude and emotional composure in a team environment.
  • Makes quality decisions independently
  • Well versed in plant operations, GMP requirements and ICH guidelinesOUR COMMITMENTAll 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: Lykan Bioscience, Worcester , Director, Quality Control, Executive , Hopkinton, Massachusetts