Research Scientist – Biotech R&D PCT MS

Lupin Ltd; Indiana (PA); On-site; USD 110,000 - 160,000; Full time

Job summary

Lupin Ltd seeks an experienced researcher to drive LC-MS based biosimilarity studies. The role includes planning experiments, method development, and mentoring a team in LC-MS workflows and data interpretation.

You will draft reports for CMC/RA dossiers and collaborate cross-functionally on impurity characterization, CAPA and safety compliance, while evaluating new technologies to enhance capabilities.

Qualifications

• 5–10 years of experience in LC-MS-based biosimilarity studies.
• Advanced degree in biotechnology or biopharmaceutics is required.

Responsibilities

• Characterize products using LC/MS for biosimilarity studies.
• Train on advanced LC-MS applications and DQA SOPs.
• Plan experiments and design data-driven workflows.
• Draft and review reports for CMC/RA dossiers and biosimilarity assessments.
• Mentor team in LC-MS workflows and data interpretation.
• Support cross-functional impurity characterization initiatives.
• Develop and qualify analytical methods; prepare comprehensive reports.
• Procure instruments and evaluate new technologies for in-house capabilities.
• Ensure CAPA, deviation and safety policy compliance.

Skills

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

Education

Masters in Biotechnology or Biopharmaceutics

Doctorate in Biotechnology or Biopharmaceutics

Job description

Job Description

• Product characterization using LC/MS for biosimilarity studies.
• Training related to advanced LC-MS applications and DQA SOPs.
• Planning of experiments.
• Drafting and/or review reports and presentations on experimental data and scientific outcomes for CMC / RA for dossier submission, method qualification, assessing biosimilarity etc.
• Guiding and mentoring team members Sample preparation, LC-MS workflows and data interpretation.
• Support cross-functional analysis such as impurity characterization.
• Method Development, Qualification and report preparation.
• Procurement related to new instruments. To assess new technologies to enhance in-house scientific and technological capabilities.
• Comply to quality aspects (CAPA, CC, Deviation).
• Comply to safety norms and attend safety training.
• To ensure compliance to all KAVACH and EHS Policies.
• Any responsibility advised by the superior from time to time.

Work Experience

5 to 10 years.

Education

• Masters in Biotechnology or Biopharmaceutics
• Doctorate in Biotechnology or Biopharmaceutics

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility