Job Description

Job Description

Job Description

Job Overview:

We are seeking a highly skilled Bioanalytical Scientist for a part-time, contract position to support drug development programs. This role involves developing and qualifying anti-drug antibody (ADA) assays, and pharmacokinetic (PK), potency assays to support CMC activities, as well as analyzing study samples. The ideal candidate will have extensive experience in PK and ADA assay development, troubleshooting, and serum/plasma and tissue sample analysis, particularly for protein and antibody-based therapeutics.

Experience with potency assays (ELISA-based or cell-based) is a plus but not required. This position offers an exciting opportunity to contribute to bioanalytical functions, assist in transferring assays to Contract Research Organizations (CROs), and support the bioanalysis of nonclinical study samples. The successful candidate will demonstrate scientific integrity, enthusiasm, and a collaborative spirit.

Pay: $65-$70 per hour

Duration: 9-12 month contract

Hours : 32-35 hours per week

Position: 100% on-site. Part-time and contract

Key Responsibilities:

· Develop and qualify PK and ADA assays to meet program-specific needs, ensuring high-quality, reproducible results.

· Troubleshoot assay issues and optimize methods to ensure data accuracy and integrity.

· Prepare and analyze study samples.

· Summarize bioanalytical results; write detailed technical reports; and assist in developing workflows to support CMC, business development activities, and regulatory filings.

· Collaborate closely with internal teams to ensure timely execution of assays and achievement of program milestones.

· Assisting in conducting, QC review, and reporting studies to ensure data accuracy and report quality.

Support potency assay activities (ELISA-based or cell-based) if experience and program needs align.

Requirements

· A master’s degree in biology, biochemistry, or a related discipline with a minimum of 5 years of experience in the biotechnology or pharmaceutical industry. A PhD is preferred, with a minimum of 2 years of post-degree industry experience.

· Extensive hands-on experience in developing and executing immunoassays and analyzing serum/plasma and tissue samples. Experience with potency assays (ELISA-based or cell-based) or familiarity with CMC analytical expectations is a plus.

· Proficiency with immunoassay platforms such as ELISA, MSD, and Gyrolab, and expertise in PK and ADA assay design, development, and qualification/verification.

· Knowledge of bioanalytical and immunogenicity guidelines (e.g., FDA/EMA) is highly desirable.

· Strong organizational skills, attention to detail, and the ability to adapt quickly to evolving project needs. Effective communication skills and the ability to work independently are essential.

· This is an on-site position in a collaborative lab environment, requiring daily in-person interactions with cross-functional teams.

Benefits

The Company

Surrozen is a biotechnology company focused on discovering and developing novel regenerative medicines with a focus on unlocking the powerful self-renewal properties of the body through specific control of the Wnt signaling pathway.

Surrozen was founded by five leading-edge scientists: K. Christopher Garcia, Ph.D., Roel Nusse, Ph.D. and Calvin Kuo, M.D., Ph.D. from Stanford University; Claudia Janda, Ph.D. from the Princess Maxima Center for Pediatric Oncology; and Hans Clevers, M.D, Ph.D. from the Hubrecht Institute and Princess Maxima Center. Each has conducted extensive research on Wnt signaling, with findings that together shape Surrozen’s technology and approach to therapeutic development.

Job Tags

Similar Jobs