BioPhase
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
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$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
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