QCTS Senior Analyst – Contract

RoslinCT; Hopkinton (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Educational Assistance

401(k)

Job summary

RoslinCT seeks a Quality Control Technical Services Senior Analyst (Contractor) to lead analytical method lifecycle activities in a cGMP cell therapy environment. You will write SOPs, develop test methods, and support method transfers, validations, and stability studies while ensuring compliant documentation.

You will work with QC and QA to ensure timely analytics, participate in stability testing, and contribute to a fast-paced manufacturing operation on-site in Hopkinton, MA.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5+ years of analytical laboratory experience in a cGMP QC setting.
• Experience with qPCR, Flow Cytometry, ELISA, or cell-based assays.
• Knowledge of analytical method lifecycle, ICH guidelines.
• Excellent written and verbal communication; strong troubleshooting.

Responsibilities

• Write/review SOPs and test methods for analytical methods lifecycle.
• Support method transfer, qualification, validation, and stability studies.
• Collaborate with QC and QA to ensure GMP documentation and right-first-time results.
• Support data compilation and routine QC testing for reporting to partners.
• Assist in scheduling and monitoring QCTS activities and stability studies.

Skills

Analytical lab work

cGMP QC

qPCR

Flow Cytometry

ELISA

Cell-based assays

ICH guidelines

Troubleshooting

Prioritization

Team collaboration

Education

Bachelor’s degree in scientific discipline

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.

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.