Sr. QC Manager, Flow Cytometry & Molecular at RoslinCT

Hopkinton, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Mar, 26

Salary

0.0

Posted On

01 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Flow Cytometry, Molecular Biology, Quality Control, cGMP, Analytical Methods, Team Leadership, Problem Solving, Data Analysis, Training, Method Development, Communication, Documentation, Troubleshooting, Project Management, Regulatory Compliance, Microsoft Office

Industry

Biotechnology Research

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 Senior Manager, Flow Cytometry & Molecular is responsible for providing daily management of lab operations (people, process, product) within Quality Control, with focus on in-process and product testing for cell products with analytical methods such as cell based assays, qPCR, dPCR, ddPCR, ELISAs, flow cytometry and related methods. This position provides scientific support to the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing. This role will spend time in the laboratory educating and training staff and executing assays and part time collaborating with Analytical Development and partner representatives. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot. How You Will Make an Impact: * Select, develop/train, manage and evaluate QC staff to ensure site objectives are met. * Manage sampling plans and testing schedules for Client product, including the management of outsourced testing. * Support the implementation of new QC methods, including equipment acquisition, method procedure, and qualification protocol development. * Support the QMS elements related to QC (deviations, CAPA, change control) as needed to support Client production. * Operate and maintain flow cytometer and PCR instrumentation (e.g FACSLyric). * Perform immunostaining for multi-color flow assays and generate, analyze and interpret flow cytometry data. * Provide scientific guidance, training, and support for method transfers/qualification/validation and routine testing of in-process, final product, and stability samples. * Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. * Review all data in accordance with applicable procedures and cGMP requirements. * Author, review, and/or approve SOPs, Test Methods, and other procedures required to operate a QC laboratory. * Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. * Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. * Communicate effectively with cross-functional peers, department management, and partner representatives. * Other duties as assigned. What You Will Bring: * Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire team to achieve project goals. * Build a culture based on company values. * A highly organized work style that ensures timely execution of tasks. * A mindset that ensures accurate results. * Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). * Effective problem-solving capabilities. * Strong oral and written communication skills. Qualifications: * Bachelor's Degree in scientific discipline. * 10+ years cGMP biotech/pharmaceutical Quality Control, including laboratory experience. * Minimum 5 years leadership experience as a Manager, Senior Scientist or as a Team Lead. * Thorough knowledge of cGMP/ICH/FDA regulations * Ability to independently prioritize/manage activities for self and direct reports. * Proficient in MS Office applications and information technologies that support documentation and data management systems. * Strong troubleshooting and problem-solving skills. * Excellent oral and written skills. * Ability to multi-task and interact with multiple groups in a team-oriented environment. WORKING CONDITIONS * Monday-Friday, 1st shift (e.g., 8am-5pm). * Flexible shift work including weekends. May be required on occasion in support of 24/7 manufacturing operations. PHYSICAL REQUIREMENTS * 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. 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.

Responsibilities

The Sr. QC Manager is responsible for managing lab operations within Quality Control, focusing on in-process and product testing for cell products. This role includes providing scientific support during technology transfer, method qualification, and routine GMP testing.