Analytical Scientist, Bioassay

This is a fully remote position, open to applicants in India.

📋 Description

• Evaluate and thoroughly analyze analytical data, studies, and technical documentation.

• Prepare and review protocols and reports for method qualification and validation.

• Identify and document deviations, unexpected results, and out-of-specification investigations that arise during analytical studies.

• Develop scientific reports and assessments that support analytical similarity and comparability, stability, forced degradation, and product characterization.

• Work collaboratively with laboratory scientists, Quality Assurance, Regulatory Affairs, and other technical departments.

⛳️ Requirements

• Bachelor's degree in Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related discipline.

• Proven experience in analytical development, qualification or validation, quality control, or similar biopharmaceutical activities.

• In-depth knowledge of cell-based potency assays, binding assays, ELISA, and related bioanalytical techniques.

• Exceptional scientific judgment, data interpretation, and technical writing abilities.

• Solid understanding of applicable ICH, FDA, USP, and GMP regulations.

• Experience with HCP, residual DNA, residual Protein A, or other process-related impurity assays is a plus.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Collaborative and inclusive work environment.