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
Didn't find what you're looking for? Search again!
Loading more jobs...