QC Sr Analyst Flow Cytometry and Molecular

About the role

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 Quality Control Sr. Analyst with a specialty in Flow Cytometry and Molecular assays will be executing analytical method transfer to Quality Control, optimize and troubleshoot assays for improvement. They will be responsible for authoring protocols, authoring Standard Operating Procedures (SOP’s) and Test Methods, executing various quality control methods, analyzing and reporting data, and assisting in the implementation of new assay methodologies and the associated instrumentation. This position is highly visible in the organization and requires the ability to interface with multiple groups.

Responsibilities

• Conduct routine and non-routine analyses of samples for in-process, final product, and stability samples.
• Execute sampling and QC sample management activities per procedure or written protocols.
• Experience in cell-based assays, Flow Cytometry, ELISA, qPCR, dPCR.
• Execute and support GMP cell culture and cell based assays for In-process, release, stability and method qualification activities.
• Perform aseptic cell culture techniques, including cell thawing, expansion, maintenance, counting, viability assessment, harvesting and preparation of cells for downstream testing.
• Maintain cell lines ensuring appropriate documentation, traceability, storage and inventory controls, as needed.
• Complete documentation for QC testing activities including data reports, reagent preparation, equipment logs and inventory logs.
• Write/revise QC specific procedures and protocols.
• Troubleshoot technical issues with assays.
• Train and mentor QC analyst on all the approved methods, GMP documentation and laboratory best practices.
• Support implementation of information technologies that support documentation and data management systems.
• Own investigations, change controls and CAPAs.
• Other duties as assigned.

Requirements

• Bachelor's degree in scientific discipline.
• 6+ years' experience in Quality Control manufacturing environment.
• Familiarity/experience in a cGMP QC laboratory is desirable.
• Ability to adhere to timelines for testing and reporting of data.
• Ability to function in a team-oriented environment.
• Excellent/Effective written and verbal communications skills.
• Adhere to scheduled timelines while maintaining flexibility and attention to detail.
• Ability to work in a fast-paced, collaborative environment and able to manage workload based on changing priorities.
• Weekend and Holidays are required.
• Flexible shift work may be required on occasion in support of 24/7 manufacturing operations.
• Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks.

Qualifications

• Bachelor's degree in scientific discipline.
• 6+ years' experience in Quality Control manufacturing environment.

Skills

• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.
• Strong oral and written communication skills.

Benefits

• Medical, dental, and vision insurance.
• Educational assistance.
• 401(k) program.
• A variety of additional resources to help you thrive both personally and professionally.