Senior Specialist, QC Support, Cell Therapy

Position Summary

The Senior Specialist position manages the lifecycle activities of QC laboratory equipment. May serve as the QC equipment system owner.

Duties/Responsibilities

• Manage the lifecycle activities of QC laboratory equipment. May serve as the QC equipment system owner.
• Create equipment User Requirement, validation protocols and equipment related documents.
• Collaborate with QC laboratories, Site Engineering, Facility Services, and other departments for the commissioning and decommissioning of laboratory equipment.
• Schedule, facilitate and participate in performing the qualification, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors.
• Maintain equipment records in accordance with GMP requirements and written procedures.
• Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Train and mentor others on equipment lifecycle process and procedures as applicable.
• Perform document revision, project, CAPA and deviation/ investigation, change management actions, related tasks and/ or continuous improvement efforts.
• Review GMP documentation/ records, including vendor executed validation documents for GDP adherence.
• Perform other tasks as required to support the QC laboratories.

Reporting Relationship

• This position will report to QC management.

Specific Knowledge, Skills, Abilities

• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Bachelor's degree or equivalent required, preferably in science.
• Advanced degree preferred. Netherlands: MLO level 4 required.4+ years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment.Advanced knowledge of computerized systems and enterprise applications such as SAP, Valgenesis and Maximo preferred.
• Demonstrated technical writing skills.
• Working knowledge of data integrity principles preferred.
• Demonstrated experience with equipment qualification and validation.

Additional information

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Devens - MA - US: $91,180 - $110,488

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

How We Work

• Where you work matters - because collaboration, innovation and patient impact happen in many settings.
• Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design.
• The model assigned to this role is based on its core responsibilities.

Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

• If this posting is missing required information required by local law or incorrect, contact BMS at with the Job Title and Requisition number.
• Do not send application-related inquiries to this email.
• To check your application status, please login to your Candidate Home Account.

R1607709: Senior Specialist, QC Support, Cell Therapy