Senior Scientist - Potency Assay

Get AI-powered advice on this job and more exclusive features. 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 assays measuring the potency of covalent biologics for different modalities in support of 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: ·Advanced degree (PhD or MS) in biology, biochemistry, or a related field. ·A minimum of 5 years of industry experience in potency assay development. ·Proven hands-on experience in the development and qualification of recombinant and cell-based potency assays including but not limited to those designed to measure target binding and induction of drug-dependent signaling including cytotoxicity for GMP implementation. ·Experience with data analysis software such as PRISM, Softmax Pro, or similar tools. ·Strong ability to engage and communicate effectively with cross-functional internal teams and external CDMOs. Additional Experience Preferred but Not Required: ·Previous work with CDMOs and involvement in regulatory submissions is a plus. ·Experience with process impurity testing, including assays for bioburden, host cell proteins and DNA, and leached protein A. 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 $145,000.00 – 165,000.00 per year Supplemental Pay Types: 401(k) Employee assistance program Flexible spending account Health insurance Life insurance Parental leave Relocation assistance Vision insurance End of year shutdown Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

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