Microbiological Scientist
About The Position
The Scientist will support microbiology-related methods such as endotoxin, bioburden, sterility, and other compendial methods associated with microbial control. Hands-on laboratory work includes method troubleshooting and involvement in evaluating new technologies related to rapid microbiology methods, including developing and executing feasibility and/or validation studies. The candidate will be required to work in the laboratory to support feasibility and/or validation studies (time spent in lab varies depending on projects). Experience in pharmaceutical/biotechnology microbiology and manufacturing is preferred. The candidate would be a part of a team that supports various microbiology methods in various stages of the product life cycle. This team supports programs/methods at locations throughout the company. The Scientist collaborates with representatives from key functions within Process Development, Manufacturing, and Quality.
Requirements
- Experience in QC Microbiology Lab
- Knowledgeable on regulations (FDA CFRs, EMA Annex 1, Pharmacopeias)
- Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation
- Industry experience in biopharmaceutical manufacturing is ideal
- Doctorate Degree OR Master's Degree and 4 years of Scientific Experience OR Bachelor's Degree and 6 years of Scientific Experience
Nice To Haves
- Prior experience in Microbiological Quality at the technical level, including experience with sterile filtration validations
- Advanced understanding and hands-on experience in various analytical platforms such as compendial microbial methods, rapid methods for microbial detection/identification, and advanced technologies for detection of bacteria
- Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
- Advanced ability to critically analyze and interrogate various analytical data sets (e.g., complex dilution schemes) to drive and influence the investigational process
- Advanced root cause analysis capabilities including leading advanced and complex events
- Advanced ability to propose and lead new scientific imperatives/initiatives
- Expert in an investigational laboratory setting within a pharmaceutical or biotechnology company
- Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations
- Familiarity with cGMP regulations, FDA and EU regulations and guidelines
- Experience in pharmaceutical/biotechnology microbiology and manufacturing
Responsibilities
- Work on validations/studies to support QC labs as needed (e.g., rapid micro methods, LER troubleshooting)
- Help develop/execute sterile filter validations internally
- Attend meetings with QC
- Assist in reviewing regulation and pharmacopeia changes and determine overall impact, as well as protocols/summary reports executed by contract testing labs
- Provide micro method technical support as needed
Benefits
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
