QCTS Senior Analyst – Contract

RoslinCT US; Hopkinton (MA); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) program

Educational assistance

Job summary

RoslinCT US is seeking a Quality Control Technical Services Senior Analyst - Contractor to support optimization, qualification, transfer, and verification of analytical methods for cGMP cell therapy production.

The role involves writing SOPs, test methods, and data capture forms; supporting analytical method lifecycle activities; and coordinating analytical method and stability study executions with QC/QA. On-site 8:00AM–5:00PM schedule with potential flexible shifts.

Qualifications

• Bachelor’s degree in scientific discipline required.
• Minimum 5+ years of analytical laboratory experience.
• Experience in a cGMP QC laboratory environment.
• Familiarity with analytical method lifecycle guidances (e.g., ICH).
• Experience with qPCR, Flow Cytometry, ELISA and/or cell-based assays.
• Excellent written and verbal communication skills.
• Strong troubleshooting and problem-solving abilities.
• Ability to prioritize multiple projects and meet timelines in a team setting.

Responsibilities

• Write and/or review SOPs in support of method lifecycle and stability programs.
• Write and/or review test methods and data capture forms.
• Review protocols and reports for analytical methods and stability studies.
• Support analytical method executions including transfer, qualification, validation, and verification.
• Collaborate with QC/QA to compile method and stability study data with accuracy.

Skills

Analytical laboratory experience

cGMP QC laboratory environment

Written and verbal communications

Prioritization of objectives

Team-oriented and collaborative

Fast-paced environment adaptability

Education

Bachelor’s degree in scientific discipline

Tools

qPCR

Flow Cytometry

ELISA

Cell-based assays

Job description

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) Senior Analyst - Contractor will be responsible for working under guidance of Associate Director responsible for optimization, qualification, transfer, and verification of analytical methods associated with cGMP production of cell therapy products. He/she will be responsible for writing standard operating procedures (SOPs) and test methods; compiling and organizing analytical method executions; supporting timely analytical method executions in compliance with all applicable quality systems and current cGMPs. He/she may also support data compilation and organization of routine QC laboratory testing for reporting to partners, scheduling and monitoring of QCTS activities, and stability studies as needed.

HOW YOU WILL MAKE AN IMPACT

• Write and/or review standard operation procedures (SOPs) in support of method lifecycle and stability programs.
• Write and/or review test methods and associated data capture forms in support of analytical methods for cell therapy products.
• May review protocols and reports in support of analytical methods and stability studies.
• Support analytical method executions related to analytical method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
• Work collaboratively with Quality Control and Quality Assurance to compile analytical method and stability study executions in compliance with GMP good documentation practices with a right-first-time approach.

Minimum Qualifications

• Bachelor’s degree in scientific discipline
• 5+ years of analytical laboratory experience
• Experience in a cGMP QC laboratory environment
• Knowledge of analytical method lifecycle guidances (e.g., ICH)
• Experience in qPCR, Flow Cytometry, ELISA, and/or cell-based assays
• Experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain, mycoplasma)
• Excellent/Effective written and verbal communications skills
• Developed troubleshooting and problem-solving skills
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail
• Ability to function in a team-oriented environment
• Ability to work in a fast-paced, collaborative environment, working with minimal direction (once training has been completed) and able to manage workload based on changing priorities

*This role is an on-site position required to support a standard 8:00 AM – 5:00 PM business day. Flexible shift work may be required on occasion in support of 24/7 manufacturing operations.

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.