Senior Specialist, QC Analytical, Cell Therapy
Bristol Myers Squibb
Summary
Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
Job description
Position Summary
Responsible for supporting QC testing for in-process, final product, and stability samples, including data review/verification. Perform method troubleshooting, training, and transfer/validation. Execute document revisions, projects, deviations/investigations/CAPA, and continuous improvement efforts.
Shift: Sunday to Wednesday 1:30pm to 11:30pm
Duties/Responsibilities
- Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
- Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
- Perform data verification, data review and review of GMP documentation for general and complex methods.
- Perform document revision, project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
- Train and mentor others on QC test methods, processes and procedures.
- Perform other tasks as assigned.
Qualifications
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- 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.
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
Job Safety Requirements & Essential Physical Demands
- Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height.
- Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or maneuver carts to transport materials between locations.
- Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
- Ability to independently don, doff, and wear required personal protective equipment such as lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
- Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
- Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
- Ability to use step stools while reaching and handling materials.
- Ability to work in a Biosafety Level 2 (BSL-2) environment.
Requirements
- Ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements
- Demonstrated technical writing skills
- High problem-solving ability, technically adept and logical
- Ability to communicate effectively with peers, department management and cross-functional peers
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred
- Ability to work in a Biosafety Level 2 (BSL-2) environment
- Ability to perform lifting tasks up to 20 lbs
- Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Flexible Time Off
- Paid Company Holidays
- Paid Sick Leave
- Paid Volunteer Days
- Summer Hours Flexibility
- Leaves of Absence
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.