Lead Cell Processing Associate 3rd Shift

Job Description

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

This is a third shift role reporting to the Senior Manufacturing Manager. This position's core responsibilities are focused on leading a team in the manufacturing processes related to cell therapies. Activities include aseptic sampling of products in a Grade A environment, operating automated, single-use systems for the targeting, expansion, and harvesting. Operate and maintain cell processing equipment. The Lead Cell Processing Associate will lead a team supporting inventory management, suite cleaning, and setup activities per RoslinCT’s governing procedures. This position will require the individual to collaborate and support MS&T and other cross-functional teams during off-hours.

HOW YOU WILL MAKE AN IMPACT

· Lead a team that directly supports Manufacturing and GMP support activities to ensure seamless production across shifts.

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

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

· 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.

· Support inventory management, material kitting, and transfers in compliance with established SOPs.

· Ability to lead, train, and mentor direct reports.

· Represent the manufacturing team in cross-functional and client-facing interactions.

· 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 the Supervisor or Manager

Qualifications

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

· Ability to lead a GMP suite and drive escalations to management

· Prior MFG Cell therapy experience.

· 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 who works well independently and within cross-functional teams

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

Full-time