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 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
Annual Salary:
$145,000.00 – 165,000.00 per year
Supplemental Pay Types:
Bonus pay
Benefits:
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