Analytical Scientist Bioassay, Qualified Technical Reviewer (QTR) - India

Alvotech

310d

About The Position

We are seeking a highly motivated individual to play a critical role in ensuring the accuracy, reliability, and compliance of analytical testing data, method validation reports, and various scientific documentation. If you are passionate about analytical science and want to contribute to cutting-edge research and product development, we encourage you to apply!

Requirements

• Degree in Biology, Biochemistry, Chemistry, Pharmaceutical Sciences, or a related field.
• Experience in analytical method execution, development, validation, quality control, or regulatory compliance within the pharmaceutical, biotechnology, or related industry.
• Proficiency in analytical involving cell-based potency testing and other bioassays including ELISA based methods for quantifying process related impurities from cell reactors (HCPs, rDNA, rProA, etc).
• Understanding of regulatory guidelines (e.g., FDA, ICH, USP, GMP, GLP).
• Excellent data interpretation and report writing skills with attention to detail.
• Ability to work collaboratively in a fast-paced environment and communicate findings effectively.

Responsibilities

• Review and analyze R D analytical testing data to ensure accuracy, completeness, and compliance with regulatory standards.
• Evaluate method validation data to confirm suitability for intended use.
• Interpret and assess various reports and datasets related to product quality, stability, and performance.
• Ensure compliance with industry regulations, company policies, and quality assurance guidelines.
• Collaborate with laboratory personnel, quality assurance teams, and regulatory departments to address data inconsistencies or trends.
• Prepare technical summaries and reports, providing clear documentation of findings and recommendations.

Benefits

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration, and inclusion.
• Positive, flexible, and innovative work environment.
• A clear and developed organizational structure.
• Training and global opportunities to advance.
• A good work-life balance.
• Home internet and home office equipment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree