Sr. QC Analyst, Microbiology
Apply NowCompany: The Lykan Bioscience Hold
Location: Hopkinton, MA 01748
Description:
WHO WE ARE
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and 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 RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE
Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance.
Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods.
Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
Ability to prepare technical data and present to senior leadership.
WHAT YOU WILL BRING
Bachelor's degree in Biology (Microbiology)
4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
Excellent/Effective written and verbal communications skills.
Prepare technical data and present to senior leadership.
Escalate issues professionally and on a timely basis.
OUR COMMITMENT
All RoslinCT employees embrace the principles of our 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.
RoslinCT 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.
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.
THE ROSLINCT WAY
Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and 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 RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.
ACCELERATING YOUR FUTURE
Author, review, approval, and final authorization of microbiology methods (test results and records, test methods, equipment records) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
Support microbiology equipment installation and qualification, ensuring 21 CFR Part 11 compliance.
Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
Provide support to QC Operations as method SME: develop training approach, training documents and provide training for new methods.
Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
Ability to prepare technical data and present to senior leadership.
WHAT YOU WILL BRING
Bachelor's degree in Biology (Microbiology)
4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
Excellent/Effective written and verbal communications skills.
Prepare technical data and present to senior leadership.
Escalate issues professionally and on a timely basis.
OUR COMMITMENT
All RoslinCT employees embrace the principles of our 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.
RoslinCT 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.