Senior Specialist, Quality Control Analytical Testing

Purpose And Scope Of Position

The QC Senior Scientist supports the analytical testing at QC Analytical Testing department at the CAR T manufacturing facility during clinical and commercial phases. This department performs flow-cytometry and molecular based testing for stability, validation, critical reagent qualification, training, and other critical support as needed.

REQUIRED COMPETENCIES (Knowledge, Skills, And Abilities)

• Advanced hands-on experience with various analytical techniques including flow-cytometry, molecular techniques and scientific knowledge in the characterization and transfer of pharmaceutical products.
• Advanced ability to accurately understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Advanced technical writing skills, problem-solving ability/mentality, technically adept and logical thinking.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Ability to work with management locally and globally.
• Advanced ability to communicate effectively with peers, department management and cross-functional peers.

Duties And Responsibilities

• Perform testing of the QC Analytical Testing Department including:
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Perform cell based in-vitro flow experiment, ELISA, qPCR to assess critical regent concentration.
• Capable of handling complex issues and solving problems with only general guidance.
• Prepare and present continuous improvement projects to management.
• Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
• Complete all work in a timely manner. Perform peer review of testing data. Review all data in accordance with applicable procedures and cGMP requirements.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Complete all reviews in accordance with required release timelines.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
• Support document revision, project, CAPA, and investigation/deviation tasks.
• Perform assigned tasks within a CAPA, deviation, or project.
• Take a leadership role, as required, for projects.
• Draft and review technical documents, such as SOPs and protocols/reports.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.

WORKING CONDITIONS (US Only)

• The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
• The incumbent must analyze numerical values on a daily basis.
• The incumbent will be working a laboratory setting up to six (6) hours per day.
• The incumbent will be working around biohazardous materials, including chemical agents up to six (6) hours per day.

Compensation Overview

• SUMMIT WEST - NJ - US: $40.97 - $49.64 per hour

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits

• Paid Time Off

On-site Protocol Responsibilities

• BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

Supporting People With Disabilities

• BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process.