Analytical Scientist Physicochemical, Qualified Technical Reviewer

3 weeks ago

Bengaluru, India 50skills Full time

Are you an experienced Analytical Scientist with a keen eye for detail and a passion for data integrity? Have you worked with biological products such as monoclonal antibodies?

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

Key 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.

Qualifications & Requirements:

  • Degree in Chemistry, Biochemistry, 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 techniques such as HPLC, CE, UV-Vis, and other laboratory instrumentation used for physicochemical testing of biopharmaceuticals, in particular monoclonal antibodies.
  • 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.

What we offer:

  • 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.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We're purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let's create a healthier world together, through affordable biologic medicines.

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