Research Scientist – Biotech R&D PCT MS
Lupin Ltd · Marion County, IN · 2 wk ago
AnalystFull-time
About the role
This position focuses on product characterization, method development, and scientific reporting for biosimilarity studies and regulatory submissions.
Responsibilities
- Perform product characterization using LC/MS for biosimilarity studies.
- Provide training on advanced LC-MS applications and DQA SOPs.
- Plan and execute experiments.
- Draft and review reports and presentations on experimental data and scientific outcomes for CMC/RA dossier submissions, method qualification, and biosimilarity assessments.
- Guide and mentor team members on sample preparation, LC-MS workflows, and data interpretation.
- Support cross-functional analysis, including impurity characterization.
- Develop, qualify, and prepare reports for analytical methods.
- Procure new instruments and assess emerging technologies to enhance in-house capabilities.
- Ensure compliance with quality aspects (CAPA, Change Control, Deviation).
- Adhere to safety norms, attend safety training, and comply with KAVACH and EHS policies.
- Perform additional responsibilities as advised by superiors.
Requirements
- 5 to 10 years of relevant work experience.
- Master’s degree in Biotechnology or Biopharmaceutics; Doctorate preferred.
Skills
- Collaboration
- Customer Centricity
- Developing Talent
- Innovation & Creativity
- Process Excellence
- Result Orientation
- Stakeholder Management
- Strategic Agility