Senior Scientist - Potency Assay

Enlaza Therapeutics; San Diego (CA); On-site; USD 145,000 - 165,000; Full time

Job summary

Enlaza Therapeutics is seeking a senior scientist to lead the development and qualification of target binding and potency assays for biologics. This full-time role involves collaboration with research teams and overseeing assay implementation to support clinical manufacturing, offering a competitive salary and comprehensive benefits.

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k)

Employee assistance program

Relocation assistance

End of year shutdown

Parental leave

Qualifications

• Minimum 5 years of industry experience in potency assay development.
• Hands-on experience with recombinant and cell-based potency assays.
• Experience with data analysis software.

Responsibilities

• Develop GMP QC-compatible target engagement assays.
• Cultivate and manage cell lines for assay development.
• Review GMP release and stability testing results.

Skills

Communication

Data analysis

Education

PhD or MS in biology, biochemistry, or related field

Tools

PRISM

Softmax Pro

Job description

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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

• Job function

  Research, Analyst, and Information Technology

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