Looking for an incredible opportunity to join a leading global biotechnology company? The chance to work with a broad range of plasma-derived and recombinant therapies?
We are exclusively supporting our client as the build their team to work on developing analytical methods and support laboratory programs applicable to routine testing of Biological products. This particular opportunity is to join their QC team as they evaluate new technologies and ensures proper transfer and implementation to the QC Laboratory.
location: Bradley, Illinois
job type: Permanent
salary: $70,000 - 80,000 per year
work hours: 9 to 5
- Performs at the level of an Analyst III and meets the requirements of Analyst III Position Description.
- Performs required testing in accordance with methods and properly documents test results. Maintains a high level of expertise in the area's testing methods.
- Evaluates invalidity rates and analytical trends. Suggests resolutions to QC Management and implement corrective actions.
- Evaluates performance of analytical instruments and equipment and recommends new acquisition or replacements. Assists in instrument qualification process.
- Evaluates, modifies and implements analytical methodologies developed and ensures smooth transfer of methodologies to routine use.
- Authors protocols and reports for suitability studies, investigations and other studies as required to support testing or compliance issues.
- Works independently on special projects as defined by the Manager.
- Represents laboratory on company cross-functional teams.
- Proficient at programs such as Minitab and Microsoft programs.
- BS/BA degree or equivalent in appropriate science (Microbiology, Biotechnology)
- 7 years with 1-3 years in method development in related field recommended. Proven demonstration to perform in the role may also be considered.
- ?Pharmaceutical Microbiology laboratory experience is preferred
- Working knowledge of cGMPs and compendial methods
- Proficiency in microbiological testing methods including validation and troubleshooting (e.g. bioburden, sterility, growth promotion, environmental monitoring)
- Experience in microbial identification methods (MALDI, MicroSeq)
- Development of RT-PCR assays
- Manage, analyze and trend large data sets
- Knowledge of Alternative Rapid Microbiology methods and automation is a plus
skills: Microbiology, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.