Job Description
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 QC Analyst II, Analytical will partner with the analytical team on analytical methods such as cell counting, ELISAs, flow cytometry and related methods. This position will also provide support for Raw Material inspections and assist the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing. 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 Raw Material Inspections and support to maintain release of materials to manufacturing, as needed.
• Support shipment/communication of QC samples for testing at external test laboratories, as needed.
• Operate and maintain cell counting and other analytical instrumentation, as required.
• Provide support for method transfers/qualification/validation and routine testing of in-process, final product, and stability samples.
• 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 QC Laboratory SOPs, Raw Material Specifications, Test Methods, and other procedures as required.
• 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, department management, and RoslinCT partner representatives.
WHAT YOU WILL BRING
• Bachelor's Degree in scientific discipline.
• 3 + years of relevant QC experience, preferably in a regulated environment.
• Hands-on experience with various analytical techniques such as ELISAs, cell counting, flow cytometry and scientific knowledge in the characterization and transfer of analytical methods.
• Hands-on experience with Raw Material sampling or system management is a plus.
• Technical background and expertise with flow cytometry platforms a plus.
• Knowledge of cGMP/ICH/FDA regulations.
• Ability to independently prioritize/manage activities.
• Works well both independently and as part of a team. Collaborative skills and effective partnering skills.
• Proficient in MS Office applications and information technologies that support documentation and data management systems.
• Strong troubleshooting and problem-solving skills.
• Excellent 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.
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