🚀 Senior Scientist, Potency Assay

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Pay found in job post

Retrieved from the description.

Base pay range

$145,000.00/yr - $165,000.00/yr

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

$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

Mid-Senior level

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

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