Job Details

This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$145,000.00/yr - $160,000.00/yr

Sr. Scientist, Potency Assays

Comp: 145k -160k

Position Overview

We are looking for a senior-level scientist with expertise in designing, developing, and qualifying functional assays that evaluate binding and biological activity of therapeutic proteins and conjugates. This individual will play a key role in moving assays from discovery into late-stage development, supporting CMC activities, and ensuring smooth transfer to external manufacturing/testing partners. The role is highly hands-on and will involve leading assay development efforts, guiding their transfer to CDMOs, and overseeing their use in lot release, stability studies, and characterization to support clinical production.

Key Responsibilities

• Build and optimize assays suitable for GMP QC use to assess target interaction for release and stability testing of protein-based therapeutics.
• Create cell-based systems for evaluating biological potency across various therapeutic modalities, ensuring methods are QC-compatible.
• Maintain cell lines used in assay development, generating well-documented master and working cell banks.
• Identify and manage critical reagents essential for assay execution.
• Draft and review protocols, reports, and documentation supporting assay development, qualification, and transfer activities.
• Evaluate QC release and stability data, supporting investigations, OOS/OOT assessments, and deviation resolution at GMP facilities.
• Partner with CDMOs to support reference standard qualification for bioassays.

Qualifications

• Graduate degree (PhD) in life sciences such as biology or biochemistry.
• At least 5 years of relevant experience in developing functional potency assays within the biotech/pharma industry.
• Demonstrated expertise in recombinant and cell-based assay systems, including methods for binding, signal induction, and drug-dependent cytotoxicity, with application to GMP.
• Proficiency with analysis software (e.g., PRISM, Softmax Pro, or comparable tools).
• Strong communication and collaboration skills, with experience working across teams and with external partners.

Preferred Experience

• Direct involvement with CDMOs and familiarity with regulatory submissions.
• Exposure to additional analytical methods such as impurity testing (bioburden, host cell proteins/DNA, or residual Protein A).

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research and Science

Industries

• Biotechnology Research and Pharmaceutical Manufacturing