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

• 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 target binding and cell-based potency assays 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 by 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 Range

$121,000.00 – $155,330.00

Supplemental Pay Types

Bonus pay

Benefits

• Health, Dental, Vision insurance
• Flexible spending account
• Employee assistance program
• 401(k)
• Retirement plan
• Life insurance
• Relocation assistance
• Parental leave
• Flexible schedule and vacation
• Year-end winter break