Lead QC Sample Management, Cell Therapy

Job Description

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 Quality Control Sample Management Lead will be responsible for working under guidance of a QC Manager and He/she will support the receipt, delivery, shipping and disposal of in-process, release, raw material samples for QC testing for cell therapy products in compliance with all applicable quality systems and current cGMPs. He/she may also support routine QC laboratory and testing activities as needed.

How You Will Make an Impact:

· Serve as the QC Sample Management lead and gatekeeper for in-process, release, raw material, retain, and stability samples, ensuring samples are received, triaged, stored, transferred, shipped, and disposed of in accordance with approved procedures, quality systems, and current cGMP requirements.

· Coordinate sample collection, testing schedules, and delivery priorities with Manufacturing, QC laboratories, Quality Assurance, Program Management, and external testing partners to support timely testing and product disposition.

· Verify sample submissions, required documentation, labeling, chain of custody, and sample condition at receipt; escalate discrepancies, delays, or compliance risks promptly.

· Maintain accurate sample inventory and transaction records, including quarantine, released, retain, stability, and testing material inventories using applicable spreadsheets, laboratory notebooks, LIMS, or other approved tracking systems.

· Ensure appropriate sample handling, storage conditions, cold chain transfers, retention, reconciliation, and disposal practices to preserve sample integrity and traceability throughout the sample lifecycle.

· Act as the primary liaison with external contract testing laboratories, supporting quote requests, sample shipment coordination, testing timelines, result tracking, certificates of analysis, and issue resolution.

· Generate, maintain, and communicate QC sample management metrics to monitor workload, turnaround times, inventory status, right-first-time documentation, and process performance.

· Support investigations, deviations, change controls, CAPAs, audits, and inspection readiness activities related to QC sample management, raw materials, sample documentation, and laboratory operations.

· Write, revise, and review QC sample management procedures, sample handling instructions, material specifications, testing documentation, protocols, and reports as needed.

· Support routine and non-routine QC laboratory activities or analytical testing for in-process, raw material, final product, or stability samples as needed to meet business and project needs.

· Support analytical equipment installation, qualification, and compliant data practices, including 21 CFR Part 11 expectations, as applicable.

· Identify and implement opportunities to improve sample flow, inventory accuracy, documentation quality, communication, and overall QC sample management efficiency.

· Collaborate cross-functionally and model RoslinCT values by maintaining a high level of organization, attention to detail, compliance awareness, urgency, and partnership with internal and external stakeholders.

· Perform other duties as assigned.

Qualifications:

· Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, Biochemistry, Microbiology, Biotechnology, or a related field; equivalent relevant experience may be considered.

· 5+ years of experience in a GMP-regulated Quality Control, laboratory operations, sample management, manufacturing support, or related biotech/pharmaceutical environment.

· Prior experience leading, coordinating, or serving as a subject matter expert for QC sample management activities, including sample receipt, triage, storage, transfer, shipment, inventory, reconciliation, and disposal.

· Strong understanding of cGMP requirements, quality systems, data integrity expectations, Good Documentation Practices, and regulatory expectations for sample handling, traceability, chain of custody, and laboratory records.

· Experience using LIMS, electronic quality systems, inventory tracking tools, laboratory notebooks, Microsoft Excel, and other systems used to document and track sample transactions.

· Demonstrated ability to manage competing priorities, coordinate sample testing timelines, communicate risks, and drive follow-through in a fast-paced manufacturing or laboratory environment.

· Experience partnering with Manufacturing, Quality Assurance, QC laboratories, Program Management, Supply Chain, and external contract testing laboratories to support timely sample testing and product disposition.

· Knowledge of cold chain handling, controlled-temperature storage, biological sample integrity, retention requirements, stability samples, and external sample shipment practices is preferred.

· Experience supporting deviations, investigations, CAPAs, change controls, audit readiness, inspection readiness, SOP revisions, protocols, reports, and other GMP documentation is preferred.

· Familiarity with cell therapy, gene therapy, biologics, aseptic manufacturing, raw materials, in-process testing, release testing, retain samples, and/or stability programs is strongly preferred.

· Working knowledge of analytical methods and compendial or routine QC testing such as pH, osmolality/osmolarity, appearance, identity testing, qPCR, flow cytometry, ELISA, cell-based assays, or microbiological testing is a plus.

· Excellent attention to detail, organization, written and verbal communication, problem-solving, teamwork, and stakeholder management skills.

· Ability to work independently, lead by influence, support team members, escalate issues appropriately, and maintain compliance while meeting business-critical timelines.

Working Conditions

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

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

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.