Lead Cell Processing Associate

WHO WE ARE

We at RoslinCT, are 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

Reporting to the Manufacturing Supervisor, this position's core accountabilities are focused on manufacturing processes related to cell therapies. Activities include aseptic processing of product in a Biosafety Cabinet (BSC) in an ISO V environment, operation of incubators in an ISO VII environment, as well operating automated, single-use systems for the targeting, expansion and harvesting of cells. The Lead Cell Processing Associate will also collaborate as needed with peers within Manufacturing Sciences and Technology (MST), Quality and Facilities.

HOW YOU WILL MAKE AN IMPACT

· Perform daily aseptic sampling for cell count, viability and other parameters.

· Perform Equipment and Cleanroom cleaning activities in accordance with established procedures and schedule.

· Work as part of a team to execute engineering and GMP runs in close collaboration with MST and operations.

· Lead deviation and root cause analysis in the event of any discrepancies that arise during processing.

• Coordinate activities related to the processing of clinical material in automated systems as part of selection, expansion harvest and wash of cells in single use systems.

• Adhere to SOPs and cGMP regulations and accurately complete documentation associated with clinical manufacturing.

• Escalate processing and equipment issues as needed.

• Ability to train and mentor junior personnel.

• Represent manufacturing team in cross functional and client facing interactions.

• Assist with daily activities of a new cGMP facility by collaborating with Validation, MST, Facilities and Quality departments.

• Perform manufacturing processes on the floor, following validation protocols, batch records and standard operating procedures (SOPs) to ensure safe and compliant operations.

• Daily review of in-process cGMP documentation for completeness and accuracy

• Other duties as assigned by Supervisor or Manager

Qualifications

• 5+ years of experience with bachelor’s degree in biology or related scientific discipline, or equivalent combination of experience and education.

• Prior experience with biopharmaceutical manufacturing; cell or gene therapy manufacturing

• Experience with quality systems including CAPAs, deviations, and change controls.

• Knowledge of the Current Good Manufacturing Practices (cGMP's);

• Excellent skills in Microsoft Word, Excel, and commonly used Manufacturing and Quality systems

• Excellent technical writing and oral communication skills

• Driven individual that works well independently and within cross-functional teams

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

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.