Quality Control Microbiologist

Ideal candidate: Candidates that have industry experience in biopharmaceutical manufacturing.

Job Description

Scientist will support microbiology related methods such as, endotoxin, bioburden, sterility and other compendial methods associated with microbial control. Hands on laboratory work include 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 need 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 are 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.Basic Qualifications:Doctorate Degree OR Master’s Degree and 4 years of Scientific Experience OR Bachelor’s degree and 6 years of Scientific experience

Preferred Qualifications

• Prior experience in Microbiological Quality at the technical level, including experience with sterile filtration validations
• Advanced understanding and hands-on experience in various analytical platform 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 guidelinesTop Must Have Skill Sets:Experience in QC Microbiology Lab; Knowledgeable on regulations (FDA CFRs, EMA Annex 1, Pharmacopeia’s); Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation.Day to Day Responsibilities:Candidate will 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.