At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key Responsibilities:
- Develop and implement phase-appropriate analytical strategies for biosimilar development.
- Lead comparability studies between biosimilars and reference products.
- Oversee method development, validation, and transfer for characterization assays.
- Provide high-level technical expertise across biosimilar programs.
- Act as a technical lead in cross-functional teams including process development, regulatory, and quality.
- Ensure all analytical activities meet global regulatory standards (ICH, FDA, EMA).
- Support dossier preparation and regulatory submissions with analytical data.
- Work closely with internal teams and external partners (CROs, CMOs).
- Present analytical findings to senior management and regulatory bodies.
- Stay updated on emerging analytical technologies and regulatory trends.
- Drive innovation in analytical approaches and tools for biosimilar characterization.
