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Sr. QC Analyst, Technical Services

4 months ago

Hopkinton, United States Roslin CT US Holdings,LLC Full time
Job DescriptionJob Description


QCTS Sr. Analyst, Cell Therapy


Full Time
Quality AssuranceHopkinton, MA, US



WHO WE ARE 

We at RoslinCT, are 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 Services (QCTS) Sr. Analyst will be responsible for working under guidance of QCTS Manager responsible for optimization, qualification, validation, transfer, compendial verification, stability, and QC implementation of methods associated with cGMP production of cell therapy products. Responsible for collaborating with Analytical Development (AD) and partner representatives on test methods to support testing of cell therapy products. This includes collaborating on writing protocols, standard operating procedures (SOPs), test methods, reports, and participating in method lifecycle activities. Analyst will support new equipment onboarding and qualification and the implementation of methods in QC in compliance with all applicable quality systems and current cGMPs. Analyst may support non-routine/routine QC laboratory and testing support activities as needed.

HOW YOU WILL MAKE AN IMPACT 

· Author and/or review test methods, protocols, and/or reports in support of methods for cell therapy products.

· Execute procedures for methods in support of method lifecycle activities including method optimization, qualification, validation, transfer, compendial verification, stability, and performance monitoring. Complete and compile data in accordance with cGMPs in a timely manner.

· Support installation and qualification of new QC equipment for implementation of methods, ensuring 21 CFR Part 11 compliance.

· Provide support to QC Operations as method SME: develop training approach, training documents, and provide training of analysts for new methods.

· Communicate effectively with peers and work collaboratively with cross functional departments including but not limited to Analytical Development, Quality Assurance, and Program Management.

· Collaborate with Analytical Development personnel to ensure methods are suitable for transfer to QC for implementation.

· Escalate and assist in the resolution of complex issues in effective ways and suggest solutions.

· May participate as a method subject matter expert (SME) in investigations, deviations, change controls, and CAPAs to support cGMP operations.

· May perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.

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

Minimum Qualifications 

· Bachelor’s degree in scientific discipline

· 5+ years of laboratory experience with Bachelor’s degree or 3+ years with a Master’s degree

· Excellent/Effective written and verbal communication skills with the ability to work as a team player where individual initiative, collaboration, and accountability are highly valued

· Experience in a cGMP QC laboratory environment

· Ability to analyze and interpret data

· Experience maintaining and operating analytical instrumentation

· Knowledge of analytical method lifecycle guidances (e.g., ICH)

· Experience in cell-based assays, Flow Cytometry, ELISA, qPCR and/or dPCR

· Experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain, mycoplasma)

· Adaptable and flexible in response to a dynamic operating environment

· Ability to work independently with review at critical points

Working Conditions/Physical Requirements

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

· Flexible shift work may be required on occasion in support of 24/7 manufacturing operations. Early morning, evening, or weekend work may be required occasionally for limited duration to support key project activities.

· 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.