- Participate as microbiology method subject matter expert (SME) in investigations, OOS, deviation, change controls, and CAPAs to support cGMP operations.
- Author, review, approval, and final authorization of microbiology methods (test results and records, test methods) and ensuring adherence to regulatory agency requirements, Client standards, policies, SOPs for cell therapy products and experience with EU Annex requirements.
- Analyzes data to identify and resolve contamination control issues, maintains documentation, and collaborates with cross-functional teams to support and improve contamination control strategies.
- Provide training to QC and MFG as a contamination SME: develop training approach, training documents and provide training for new methods.
- Execute procedures for microbiology methods in support of method lifecycle activities including method transfer, qualification, validation, compendial verification, and performance monitoring.
- Perform non-routine/routine QC testing for in process samples, product testing, stability testing, or raw material testing as needed.
- Work collaboratively with cross functional departments including but not limited to QC Technical Services, Quality Assurance, and Program Management.
- Ability to prepare technical data and present to senior leadership.
WHAT YOU WILL BRING- Bachelor's degree in Biology (Microbiology)
- 4+ years of microbiology laboratory experience with rapid microbiological methods is a plus (rapid sterility, endotoxin, gram stain).
- Experience in a cGMP QC laboratory environment performing environmental monitoring, contamination control and investigation writing.
- Excellent/Effective written and verbal communications skills.
- Prepare technical data and present to senior leadership.
- Escalate issues professionally and on a timely basis.
Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.
At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.
Department Quality Control Locations Hopkinton Yearly salary $70,000 - $115,000 Employment type Full-time
