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 QC Analyst II, Flow Cytometry & Molecular Team, will be executing analytical method transfers to Quality Control, optimize and troubleshoot assays for improvement. He/she will be responsible for authoring Standard Operating Procedures (SOPs) and Test Methods. He/she will be executing various quality control methods, analyzing data, and reporting data. He/she will assist in the implementation of new assay methodologies and the associated instrumentation. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.
HOW YOU WILL MAKE AN IMPACT • Perform routine and non-routine quality control testing on in-process samples and finished products. • Operate and maintain laboratory equipment and instruments,
ensuring proper calibration and adherence to cGMP
Compliance. • Provide support for method transfers/qualification/validation and stability testing. • Support analytical equipment installation and qualification • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. • Review all data in accordance with applicable procedures and cGMP requirements. • Author, review, and/or approve SOPs, Test Methods, and other procedures required to operate a QC laboratory. • Participate in internal and external audits, inspections, investigations, change controls and CAPAs • Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function. • Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. • Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements. • Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. • Communicate effectively with cross-functional peers, and department management.
WHAT YOU WILL BRING • Bachelor's Degree in scientific discipline. • 3+ years of relevant experience in cGMP Quality Control Laboratory. • Hands-on experience with various analytical techniques such as flow cytometry, qPCR, dPCR, ELISAs, cell-based assays, and scientific knowledge in the characterization and transfer of analytical methods. • Hands-on experience with Raw Material sampling or system management is a plus. • Experience with rapid microbiological methods is a plus (e.g. mycoplasma) • Knowledge of cGMP/ICH/FDA regulations. • Ability to independently prioritize/manage activities. • Ability to prioritize objectives from multiple projects and adhere to
scheduled timelines while maintaining flexibility and attention to
detail. • Proficient in MS Office applications and information technologies that support documentation and data management systems. • Strong troubleshooting, problem-solving skills, oral and written skills. • Ability to multi-task and interact with multiple groups in a team-oriented environment.
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.