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Job Details


Bristol-Meyers Squibb, Co.

Associate Scientist, Quality Control (R1559549-en-us)

Pharmaceuticals

All

Yearly

No

Warren, New Jersey, United States

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Position Summary:

This position will work both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary.

Roles and Responsibilities:

  • Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
  • 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.
  • Communicate effectively with QC peers, cross-functional peers and management.
  • Assist in troubleshooting and solving problems that may come up in the day-to-day operation of the department.
  • Ability to gown and maintain a sterile work environment.
  • Ability to work independently for extended periods of time.
  • Perform Environmental Monitoring on routine basis.
  • Collect viable and non-viable samples within controlled environments.
  • Collect viable and non-viable samples for compressed gases.
  • Collect personnel glove and gown samples.
  • Participate in aseptic process qualifications, such as aseptic gowning and media reads.
  • Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
  • Send out samples to contract labs and track results/reports.
  • Perform microbial isolation techniques and perform Gram stain identifications.
  • Perform Bacterial Endotoxin and Sterility Testing.
  • Perform growth promotion testing of microbiological media.
  • Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
  • Performs general laboratory cleaning/wipe-down.
  • Perform routine maintenance of lab equipment’s.
  • Under the guidance of management, support special project work.
  • Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices.
  • Maintain lab inventory and order lab supplies and materials.
  • Receives and stock test reagents, lab supplies and test media.
  • Support continuous improvement projects related to QC
  • Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports in support of projects.
  • Assist with investigations &CAPAs associated with Microbiological testing.
  • Enter data in CELabs LIMS System and support data trending and tracking of results.
  • Perform all other duties as assigned.

Qualifications and Experience:

  • Requires Bachelor’s degree in Microbiology, Molecular Biology, or related discipline and minimum 1-3 years of experience working in a regulated manufacturing environment. Microbiology lab experience strongly preferred. An equivalent combination of experience/education is acceptable.
  • Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
  • Good knowledge of Microsoft Word and Excel.
  • Responds to challenges and additional projects in an understanding, positive, and objective manner.
  • Adaptable to dynamic conditions, work practices, and project timelines.
  • Ability to multitask, prioritize workload and interpret data accurately.
  • Able to communicate effectively with GDPO functional areas and external agencies.
  • Fosters teamwork and promotes an environment that motivates others to achieve our goals.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART #LI-Onsite

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.