What are the responsibilities and job description for the Senior Scientist, Potency Assay position at Enlaza Therapeutics?
Senior Scientist, Potency Assay
About Enlaza Therapeutics :
Enlaza Therapeutics is a growing biotech company developing an innovative synthetic biology platform to create a disruptive new class of biologic therapeutics. We are dedicated to the development of these novel therapies to help patients suffering from cancer and other serious diseases.
Role Description :
We are seeking an experienced senior scientist skilled in developing and qualifying target binding and cell-based potency assays for protein biologics and conjugates. You will work closely with research teams to advance assays from discovery to CMC development. In this hands-on role, you will lead the development and transfer of potency assays to CDMOs, overseeing their implementation for lot release, stability, and characterization to support clinical manufacturing.
Responsibilities :
- Develop GMP QC-compatible target engagement assays to support release and stability testing of covalent biologics.
- Develop GMP QC-compatible cell-based functional assays including but not limited to cytotoxicity assays to support release and stability testing.
- Culture, maintain, and generate well-documented banks of cell lines required for assay development.
- Identify and manage critical reagents needed to develop and execute assays.
- Author and / or review technical documents for method development, transfer, verification / qualification protocols and reports.
- Review GMP release and stability testing results for potency assays. Support OOS / OOT root cause analysis, QC data review, batch release processes, and deviations / investigations at GMP facilities.
- Collaborate with the CDMO to support reference standard qualification for bioassays.
Requirements :
Additional Experience Preferred but Not Required :
Compensation :
In addition to a competitive compensation package with stock options, the company also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.
Job Type : Full-time
Annual Salary :
121,000 - 155,330 per year
Supplemental Pay Types :
Bonus pay
Benefits :