Associate Scientist, QC (Quality Control) Microbiology
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.