Senior Research Scientist : Pharma Research OOD

Lupin Limited; Pune District; Vor Ort; INR 1.800.000 - 3.200.000; Vollzeit

Zusammenfassung

Lupin Limited in Pune seeks a senior pharmaceutical development leader to drive advanced formulations, including novel controlled releases and complex generics for global markets. You will oversee design, development, data analysis and regulatory alignment, coordinating with QA, Regulatory, Clinical and Manufacturing teams.

The role requires extensive experience (>13 years) in pharma development, strong leadership, and a commitment to process excellence and innovation.

Qualifikationen

• More than 13 years of pharmaceutical development experience.
• Experience in formulation development, regulatory filings and tech transfer.
• Strong project leadership and cross-functional collaboration.

Aufgaben

• Develop novel controlled release and non-infringing formulations for complex generics and Para IV ANDAs.
• Review bio/clinical study designs and support manufacturing and labeling activities.
• Lead interactions with QC, QA, Regulatory, Marketing, and Clinical teams.
• Train and supervise researchers and oversee continuous improvement initiatives.
• Ensure adherence to ICH guidelines, SOPs and documentation for regulatory submissions.
• Drive tech transfers for scale-up and clinical/bio study batches.

Kenntnisse

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

Building a Safe Environment

Leadership

Ausbildung

Masters in Pharmaceutical Technology

Jobbeschreibung

Job Description

• 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

Competencies

Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility 1. Strategic Agility 2. Innovation & Creativity High Quality Standards Building a Safe Environment 3. Customer Centricity 5. Result Orientation 7. Collaboration 6. Process Excellence Achievement Orientation Business Communication INNOVATION & CREATIVITY Listening Skills