Senior / Principal Analyst, Quality Control
EGenesis
IT, Quality Assurance
Cambridge, MA, USA
Posted on Feb 5, 2025
COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY
eGenesis is seeking a Senior / Principal Analyst to join the Quality Control unit. You will be responsible for method transfer, qualification, troubleshooting, and release and stability testing of our innovative drug substance and products. You will ensure activities are executed in a cGMP compliant manner and play a pivotal role in the build-out of our internal Quality Control function as eGenesis expands clinical capabilities. The ideal candidate will be highly motivated, excited by technical challenges, and work well in a team environment.
PRIMARY RESPONSIBILITIES
- Lead method transfer and qualification activities in support of our pre-clinical and clinical programs
- Execute QC testing to support release and stability analysis for drug substance and drug product
- Manage method qualification and release testing conducted at contract testing organizations
- Conduct testing investigations and deviations to support root cause analysis and corrective and preventative actions, as required
- Implement QC systems and procedures compliant with cGMP
- Manage programs for critical laboratory reagents, assay controls/reference standard, and equipment
- Independently analyze and summarize data in technical reports and presentations
- Author, review, and/or approve data, logbooks, SOPs, CoAs, analytical methods, protocols, reports, deviations, and other quality records
- Maintain the QC Unit in a state of compliance and inspection readiness
BASIC QUALIFICATIONS
- BS/MS in biology, immunology, biochemistry or a related scientific discipline with at least 5-8 years industry experience
- Experience working in a regulated GMP QC laboratory is required
- Proficient in a range of analytical methods (mammalian cell culture, flow cytometry, ELISA, qPCR etc.) and aseptic technique
- Strong knowledge of US cGMP regulations/guidelines
- Detail oriented and organized with the ability to work in a fast-paced environment
- Effective communication skills, both verbal and written, across various functions including Manufacturing, Quality Assurance, and Analytical Development