Senior Research Scientist : Pharma Research OOD

Lupin; Maharashtra; Presencial; INR 2.400.000 - 3.600.000; Jornada completa

Descripción de la vacante

Lupin is seeking a Senior Research Scientist in Pharma Research to lead development of complex dosage forms, oversee tech transfer, and ensure compliance with FDA/ICH guidelines. The role demands strategic thinking, cross-functional collaboration and hands‑on leadership in a fast-paced R&D environment.

The successful candidate will have 13+ years of experience in pharmaceutical development, strong project-management and mentoring skills, and a track record of delivering innovative formulations

Formación

• Masters in Pharmaceutical Technology.
• Over 13 years of industry experience.
• Experience with pre-formulation and formulation development.
• Familiar with ICH guidelines and regulatory filings (IND/NDA).

Responsabilidades

• Lead development of novel controlled release and non-infringing formulations for complex generics and first-to-file ANDAs.
• Review bio/clinical study designs and support regulatory submissions.
• Coordinate with QC, QA, Regulatory, Marketing, Clinical and Purchasing for product development.
• Train and supervise Research associates/Scientists.
• Drive continuous improvement to improve quality and efficiency.

Conocimientos

Strategic agility

Stakeholder management

Communication skills

Process excellence

Educación

Masters in Pharmaceutical Technology

13+ years experience

Descripción del empleo

Senior Research Scientist : Pharma Research OOD

• Date: Oct 6, 2026
• Location: Pune_RD, MH, IN
• Company: Lupin
• Development of novel controlled release as well as non-infringing formulations (solid, liquid and injectable) for complex generics and first to file Para IV ANDAs for advanced (US, EU, Canada, Japan, Australia) and semi regulated markets with QBD approach. Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures. Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches.
• Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation. Maintain inventory and reconciliation of Innovator products. Ensure cost of development does not exceed its allocated cost.
• Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Maintain and follow safety standards as issued by the Company.
• Lead interaction with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products.
• Train and supervise Research associates/Trainees/Associate scientists.
• Oversee continuous improvement initiatives, which includes analyzing the development capabilities and as necessary, redefining goals and objectives to improve quality and efficiency.
• Take part in smooth functionality of department activities as per allotted KRA.

Work Experience

more than 13 years

Education

Masters in Pharmaceutical Technology

Customer Centricity

Developing Talent

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

1. Strategic Agility

High Quality Standards

Building a Safe Environment

3. Customer Centricity

5. Result Orientation

6. Process Excellence

Achievement Orientation

Business Communication

INNOVATION & CREATIVITY

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