Quality Control Scientist
EGenesis
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Cambridge, MA, USA
Posted on Nov 18, 2023
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 Scientist to join the Quality Control team. In this position you will be a key team player reporting directly to the Director of Quality Control. You will be responsible for method 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 have the opportunity to be pivotal in the build-out of our internal Quality Control function. The ideal candidate will be highly motivated, excited by technical challenges and work well in a team environment.
PRIMARY RESPONSIBILITIES
- Lead method qualification and validation activities in support of our pre-clinical and clinical programs
- Execute Quality Control testing to support release, stability and characterization analysis for drug substance and drug product
- Support analytical troubleshooting and the development of new methods
- Lead testing investigations and deviations to support root cause analysis and corrective and preventative actions, as required
- Implement Quality Control systems and procedures to establish internal GMP laboratory
- Manage programs for critical laboratory reagents, controls 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
BASIC QUALIFICATIONS
- BS/MS in biology, biochemistry or a related scientific discipline with at least 6-10 years industry experience
- Experience working in a regulated GMP Quality Control 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 and EU cGMP regulations/guidelines
- Detail oriented and organized with the ability to work in a fast-paced environment, on multiple projects is essential
- Effective communication skills, both verbal and written, at all levels and across various functions
This job is no longer accepting applications
See open jobs at EGenesis.See open jobs similar to "Quality Control Scientist" Khosla Ventures.