Lead QC Analyst, Raw Materials, Cell Therapy - Hopkinton - RoslinCT

Description

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 Quality Control/ Raw Material Lead Analyst will be responsible for working under guidance of a QC Manager and He/she will support the inspection and release of various incoming raw materials for use in the manufacturing of cell therapy products, including authoring material specifications, in compliance with all applicable quality systems and current cGMPs. He/she may also support routine QC laboratory and testing support activities as needed for analytical method analysis. He/she will be responsible for writing protocols, standard operating procedures (SOPs), and reports in support of analytical testing, as needed.

How You Will Make an Impact:

• Support QC Raw Materials program by performing raw material inspection/sampling (as needed)/approvals per written procedures
• Assist in completing material onboarding assessments, classifications and safety assessments (as applicable)
• Sample management activities—maintain quarantine, released, retain, and testing material inventory (spreadsheets)
• Maintain QC RM monthly metrics
• Perform risk assessments, create and develop material specifications and testing requirements (as needed)
• Develop programs for raw material qualification and monitoring of compendiaI updates
• Support material testing for external contract testing laboratories (quotes, shipping and test results, etc.)
• Support QC for material Supplier Change Notifications and attend Material Review Board meetings, as needed
• Write and/or review protocols, test methods, and reports in support of analytical methods for cell therapy products
• Perform non‑routine/routine QC testing for analytical methods in support of cGMP manufacturing of cell therapy products (in‑process, raw material, final product or stability) as needed
• Support analytical equipment installation and qualification, ensuring 21 CFR Part 11 compliance, as needed
• Participate as raw material method subject matter expert (SME) in investigations, deviation, change controls, and CAPAs to support cGMP operations
• Work collaboratively with cross‑functional departments including but not limited to Warehouse, Supply Chain, Supplier Quality, Quality Assurance, and Program Management
• May interact with external partners on technical matters in relation to raw materials or analytical methods
• Write/revise QC specific material specifications, procedures and protocols
• Possess the ability to evaluate various Quality Certificates of chemicals/raw materials/packaging components
• Adhere to compliance of Warehouse area in terms of Isolation of Quarantine and Released materials
• Other duties as assigned

Qualifications:

• Bachelor's degree in scientific discipline
• 5+ years of GMP QC laboratory experience (raw material testing/release is a plus)
• Knowledge in ANSI.ASQ Zl.4 sampling plans
• Knowledge of analytical method industry guidances (e.g., ICH)
• Experience in pH, osmolality, or identification procedures (experience in qPCR, Flow Cytometry, ELISA, and/or cell‑based assays is a plus)
• Excellent/Effective written and verbal communications skills
• Developed troubleshooting and problem-solving skills
• Ability to adhere to timelines for testing and reporting of data
• Possess strong organization, communication, writing, people skills/teamwork, and detail‑oriented
• Experience working in a team environment, facilitating a team approach, and communicating effectively

Working Conditions

Position is primarily M‑F during regular business hours. Evening or weekend work may be required occasionally for limited duration to support key project activities.

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.