Sr. Associate Scientist I - Microbiologist
Bristol Myers Squibb
6 months ago
On-site
Indianapolis, IN
Operations
Senior Associate Scientist I (Microbiologist) — Quality Control Microbiology (radiopharmaceutical manufacturing)
Responsibilities
- Perform routine microbiological release testing: sterility, bacterial endotoxin (BET), bioburden, and media qualification in accordance with approved methods, SOPs, and cGMP.
- Lead/support method qualification/verification/validation.
- Troubleshoot assay issues; support out-of-trend (OOT) evaluations.
- Support continuous improvement (new technologies, improved data visibility).
- Maintain aseptic technique; follow EHS policies and waste-handling procedures.
- Complete GMP documentation in worksheets/logbooks/electronic systems; review data for completeness/accuracy/data integrity; maintain inspection-ready documentation.
- Complete required GMP/safety/method training; collaborate with peers, supervisors, QA, and cross-functional partners.
Qualifications / Education / Experience
- BS/MS in Biology, Microbiology, or related life science field with 3–5 years of relevant production or QC experience in a cGMP/FDA regulated facility.
- Experience with sterile manufacturing and/or radiopharmaceuticals strongly preferred.
Skills
- Ability to work independently or in a team; strong written/verbal communication.
- Ethics/integrity and confidentiality.
- Comfortable with PPE cleanroom work, ionizing radiation; able to lift 40 lbs.
- Uses AI tools to enhance productivity/quality.
Benefits (as stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k), disability, life insurance, etc.
- Paid time off (including flexible time off/vacation and national holidays, plus additional eligibility-based leave).
Application instructions
- If intrigued but not a perfect resume match, you are encouraged to apply.
Responsibilities
- Perform routine microbiological release testing: sterility, bacterial endotoxin (BET), bioburden, and media qualification in accordance with approved methods, SOPs, and cGMP.
- Lead/support method qualification/verification/validation.
- Troubleshoot assay issues; support out-of-trend (OOT) evaluations.
- Support continuous improvement (new technologies, improved data visibility).
- Maintain aseptic technique; follow EHS policies and waste-handling procedures.
- Complete GMP documentation in worksheets/logbooks/electronic systems; review data for completeness/accuracy/data integrity; maintain inspection-ready documentation.
- Complete required GMP/safety/method training; collaborate with peers, supervisors, QA, and cross-functional partners.
Qualifications / Education / Experience
- BS/MS in Biology, Microbiology, or related life science field with 3–5 years of relevant production or QC experience in a cGMP/FDA regulated facility.
- Experience with sterile manufacturing and/or radiopharmaceuticals strongly preferred.
Skills
- Ability to work independently or in a team; strong written/verbal communication.
- Ethics/integrity and confidentiality.
- Comfortable with PPE cleanroom work, ionizing radiation; able to lift 40 lbs.
- Uses AI tools to enhance productivity/quality.
Benefits (as stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k), disability, life insurance, etc.
- Paid time off (including flexible time off/vacation and national holidays, plus additional eligibility-based leave).
Application instructions
- If intrigued but not a perfect resume match, you are encouraged to apply.