Bioanalytical Scientist - Part-Time - Contractor

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.

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.

Duration of contract: 9-12 months

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 work processes to support 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.

• A master’s or bachelor’s degree in biology, biochemistry, or a related discipline with 5-10 years of experience in the biotechnology or pharmaceutical industry
• Extensive hands-on experience in developing and executing immunoassays, and analyzing serum/plasma and tissue samples. Experience with ocular tissue matrix preparation is a plus.
• Proficiency with immunoassay platforms such as MSD, ELISA, 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.