Analyst

Key Responsibilities

• Conduct bioanalytical lab activities in compliance with established SOPs, procedures, and regulatory guidance.
• Collaborate with Study Directors, QC, and QA during data review and observation closure.
• Complete assigned tasks in a timely manner.
• Prepare reagents and maintain logs for assigned assays.
• Interpret assay results and identify potential issues.
• Participate in data discussions and presentations.
• Adhere to environment, health, and safety (EHS) requirements to ensure workplace safety.
• Attend EHS training provided by the company.

Educational Qualification

• Master s degree in Biological Sciences (preferably with a background in Biochemistry) or a related field.

Technical/Functional Skills

• Strong foundation in immunoassays and bioanalytical Pharmacokinetics and Immunogenicity Assays, aligned with regulatory guidance and industry practices.
• Hands-on experience in Ligand Binding Assay (LBA) development, validation, and sample analysis; knowledge of ELISA and MSD assays is desirable.
• Familiarity with regulatory requirements (OECD, GXP, 21 CFR Part 11, EMA, and FDA guidelines).

Experience

• 0-3 years of experience in Pharmacokinetics and Immunogenicity Assays.

Behavioral Skills

• Independent and proactive.
• Excellent communication skills (written and oral) in English.
• Strong interpersonal abilities.
• Flexible and capable of working under time pressure