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Title: Assistant Scientist, Clinical QC Sample Management-Microbiology, Development Quality Control
Location: Warren, NJ
The Assistant Scientist, Clinical QC Sample Management-Microbiology position is responsible for the movement and control of Quality Control (QC) samples and materials and execution of routine and non-routine microbiological testing in support of the QC laboratories at the CAR T manufacturing facility in Warren, NJ.
This primarily includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking, documentation, shipments as well as send out samples to contract labs and track results/reports, execution of microbial isolation techniques, Gram stain identifications, Bacterial Endotoxin, Sterility testing and microbiology laboratory maintenance functions within the cGMP operation for CTDO Developmental QC for CAR T. Additional activities also include support of multiple early phase program life cycle management, change controls and actions, CAPAs, Deviation and other support work as needed.
Key Responsibilities:
- Ensures the chain of custody of QC samples are maintained throughout the complete life span of samples: receipt, handling, storage, distribution, transfer, and destruction of QC samples at the site.
- Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures
- Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
- Performing sample queries and periodic storage reports, as required.
- Responsible for sampling clinical QC incoming materials in collaboration with warehouse personnel and CAR T QC incoming material team.
- Ability to gown and maintain a sterile work environment.
- Perform microbial isolation techniques and perform Gram stain identifications.
- Perform Bacterial Endotoxin and Sterility Testing.
- Perform growth promotion testing of microbiological media.
- Initiating and performing investigations, Deviations/CAPAs/Change Controls related to sample management.
- Prepares and presents continuous improvement projects to management.
- Performs document review related to sample management and microbiology
- Create and revise SOP, FORM, WP, and TRN related to sample management and microbiology (as needed).
- Participate in aseptic process qualifications, such as aseptic gowning and media reads.
- Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
- Enter data in CELabs LIMS System and support data trending and tracking of results.
- Provide range of support of QC services such as ordering and receipt of lab supplies.
- Establish and maintain inventory of QC incoming material, QC material retain, QC samples and QC regulatory retains.
- Coordinate and lead trainings for sample management and microbiology (as needed).
- Develop understanding and assembly of weekly process schedule assignment for drug product samples and incoming QC materials.
- Perform and/support Environmental Monitoring on routine basis/as needed (collect viable and non-viable samples within controlled environments).
- Collect viable and non-viable samples for compressed gases and collect personnel glove and gown samples (as needed).
- Assist in analytical/microbiology trouble shooting, solving problems and investigations that may come up in the day-to-day operation of the department.
- Demonstrate general understanding of root cause analysis and CAPA methodologies.
- Maintaining metrics for the sample management and microbiology group (as needed).
- Facilitating cold chain transfers of samples, as required.
- Assist with preparation and execution of equipment installations related to sample management and microbiology.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
- Follow directions properly, work cooperatively as an individual contributor and as a team member.
- Ability to work independently for extended periods of time.
- Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Perform other tasks as assigned.
Qualifications & Experience:
- Bachelor’s degree required, preferably in chemistry, microbiology, or related science.
- 2-3 years of relevant work experience, preferably in a GMP regulated environment.
- An equivalent combination of education and experience may substitute.
- Sample management and/or microbiology experience is a PLUS
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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse 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. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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