QCTS Scientist - RoslinCT : Job Details

The Quality Control (QC) Scientist, Cell Therapy, will be responsible for working under guidance of the Quality Control Technical Services (QCTS) Senior Manager 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. 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 protocols, test methods, and reports in support of methods for cell therapy products.

· Execute procedures for testing methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.

· 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.

· 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.

· May interact with external partners on technical matters in relation to methods.

· May support clinical stability.

MINIMUM QUALIFICATIONS

· Bachelor's degree in scientific discipline and 6+ years of industry experience; MS preferred

· Experience in a cGMP QC laboratory

· Ability to function in a team-oriented environment

· Knowledge and demonstrated understanding of method lifecycle guidances (e.g., ICH)

· 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

· Proficient in MS Office applications and information technologies that support documentation and data management systems

WORKING CONDITIONS

Monday-Friday, 1st shift (e.g., 8am-5pm).

Flexible shift work 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.