Specialist, Bioanalysis

Responsibilities:

Conduct bioanalytical method development including PK/ADA, and NAb assay as approrpriate, and support the assay transfer to external lab under supervision.

Hands on analysis of pre-clinical study samples in a timely manner to meet projects needs.

Work with cross-functional teams to understand bioanalytical needs for PK and immunogenicity support.

Work with procurement team for reagents ordering, manage reagents in good condition.

Assist in daily lab operations such as maintaining lab equipment and environmental health & safety,

Participate in meetings and other activities of project teams, working groups, and other relevant groups as needed to contribute to projects.

Have and maintain understanding of current international guidelines and expectations governing regulated bioanalysis.

Requirement:

Required Educational Background and Job-Related Experience

BS or MS in pharmacology, immunology, biochemistry or related fields with 0-3 years' experience.

Bioanalysis experience especially for large molecules. A diverse skillset in bioanalytical assay development methodologies such as ligand binding (ELISA, MSD, etc.) and LCMSMS.

Knowledge & Skills Required

Bioanalysis: Familiar with bioanalytical techniques and challenges, demonstrated hands-on experience and technical knowledge in bioanalytical assays

Scientific: Working knowledge of immunoassays, quantitative (PK) and immunogenicity

Efficiency: must work effectively within the team to meet objectives under time constraints.

Quality: experience in a GLP environment and demonstrated knowledge of GLP regulations, regulatory expectations (FDA, EMA, Asia-Pacific) and industry best practices for bioanalysis.

Multi-task: ability to take direction well and manage a diverse workload.

Communication: excellent oral and written communication skills.