QCTS Scientist II/Principal Scientist

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

The Quality Control Technical Service (QCTS) Scientist II/Principal is responsible for working under guidance of the Quality Control Technical Services (QCTS) Associate Director responsible for optimization, qualification, transfer, verification, and QC implementation of methods associated with cGMP production of cell therapy products. He/she will be responsible for collaborating with Analytical Development and partner representatives on test methods to support testing of cell therapy products; writing protocols, test methods, standard operating procedures (SOPs), and reports in support of methods; overseeing and/or participating in execution of method lifecycle activities; support the cellular therapy stability activities. He/she will support new equipment onboarding and qualification and the implementation of methods in QC in compliance with all applicable quality systems and current cGMPs.

HOW YOU WILL MAKE AN IMPACT:

• Write and/or review qualification/verification/validation protocols, test methods, and qualification/verification/validation reports in support of methods for cell therapy products.
• Design, develop, and execute procedures for testing methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
• Facilitate the set up of contract testing at external laboratories acting as the technical liaison.
• Support installation and qualification of new QC equipment for implementation of methods, ensuring 21 CFR Part 11 compliance.
• Participate and own investigations, deviation, change controls, and CAPAs to support cGMP operations as needed.
• Provide support to QC Operations as method SME: develop training approach, training documents, and provide training for new employees.
• Work collaboratively with cross functional departments including but not limited to Analytical Development, Quality Assurance, and Program Management.

• Interact with external partners on technical matters in relation to method transfer activities.
• Guide the successful completion of projects and may function in a project leadership role while mentoring junior staff.
• Support cell therapy stability program through protocol generation, data compilation, data analysis, and report authoring.

WHAT YOU WILL BRING:

• A highly organized work style that ensures timely execution of tasks.
• A mindset that is team based, collaborative, with a high commitment to business goals.
• Attention to detail and data integrity that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.
• Strong and effective oral and written communication skills.
• Strong background and demonstrated effectiveness with method validation and transfer for cell therapy methodology.

QUALIFICATIONS:

• Bachelor's degree in scientific discipline with 12+ years of industry experience; MS preferred
• Experience in a cGMP QC laboratory
• Knowledge and demonstrated understanding of method lifecycle guidances (e.g., ICH)
• Knowledgeable in basic statistical applications including statistics for analytical method life cycle activities
• Experience in cell-based assays, Flow Cytometry, ELISA, and/or qPCR.

• Experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain, mycoplasma)
• Excellent/Effective written and verbal communications skills
• Developed troubleshooting and problem-solving skills
• Ability to work in a fast-paced, collaborative environment, working with minimal direction (once training has been completed) and able to manage workload based on changing priorities

• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail
• Ability to communicate effectively with management regarding task completion, roadblocks, and needs

WORKING CONDITIONS

• Monday-Friday, 1st shift (e.g., 8am-5pm).
• Flexible shift work including weekends. May be required on occasion in support of 24/7 manufacturing operations.

PHYSICAL REQUIREMENTS

• Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks.

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.