Senior Specialist, Quality Control Analytical Testing

Bristol Myers Squibb • Summit, NJ

19h • $41 - $50 • Onsite

About The Position

The QC Senior Scientist is responsible for supporting the analytical testing at QC Analytical Testing department at the CAR T manufacturing facility during clinical and commercial phases. This department is responsible for flow-cytometry and molecular based testing for stability, validation, critical reagent qualification, training, and other critical support as needed. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. This is Wed-Sat day shift.

Requirements

• 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.
• Bachelor’s degree or equivalent required, preferably in science.
• 2-4 years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.

Nice To Haves

• Advanced Degree preferred.
• Experience working with sterile cell culture, polychromatic flow-cytometry panels, flow-cytometry data analysis, ELISA, and qPCR preferred.

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.
• Participate in complex projects and continuous improvement efforts.
• 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.
• Performs other tasks as assigned.

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 include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior