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Job Details


Bristol-Meyers Squibb, Co.

Associate Scientist, QC (Quality Control) Microbiology

Pharmaceuticals

All

Full Time

On Site

No

Summit, 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.

This Position qualifies for a $10,000 Sign-on Bonus, $5,000 payable within 30 days of start date and $5,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.

Purpose and Scope of Position:

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.

Duties 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.
  • Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
  • Perform Bacterial Endotoxin and Sterility Testing.
  • Perform microbial identification via polymerase chain reaction (PCR).
  • Perform growth promotion testing of microbiological media.
  • Perform mycoplasma testing via PCR.
  • Perform Environmental Monitoring on routine basis.
  • Perform microbial isolation techniques and perform Gram stain identifications.
  • Send out samples to contract labs and track results/reports.
  • 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.
  • Support data trending and tracking of results.
  • Perform all other duties as assigned.

Required Competencies:

Education and Experience:

  • Requires Bachelor’s degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Microbiology lab experience & Master’s Degree strongly preferred. An equivalent combination of experience/education is acceptable.
  • Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.

Knowledge, Skills, and Abilities:

  • 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.

BMSCART

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.