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Research Scientist

5-7 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Jr. Research Scientist – Formulation

Job Function

Innovation & Development

Location

Mumbai (Andheri MIDC)

Reporting To

Sr. Group Leader – Formulation


Purpose of the Role

To deliver formulations within defined timelines to meet product delivery goals for Innovation & Development (I&D). This includes developing generic and differentiated generic formulations, ensuring successful stability, and demonstrating scale-up feasibility at the manufacturing site.


Core Responsibilities

  • Develop formulation prototypes using scientific rationale for excipient selection.

  • Maintain proper documentation of all trials in logbooks and compile data for Product Development Reports (PDR) for dossier filing.

  • Apply Quality by Design (QbD) principles for product and process optimization.

  • Ensure upkeep, calibration, and maintenance of laboratory equipment.

  • Conduct scale-up studies to ensure successful transition of formulations to engineering batch level.


Key Deliverables

  • Conduct literature and patent searches to create comprehensive drug profiles.

  • Perform preformulation studies as required for formulation development.

  • Develop prototype formulations with rationale-based excipient selection.

  • Conduct 6-month accelerated stability studies to ensure formulation stability.

  • Execute proof-of-concept studies to demonstrate bioequivalence (BE) or comparative pharmacokinetics (PK).

  • Perform scale-up studies at 1/10th scale or engineering batch level.

  • Support technology transfer and manufacture of bio/clinical batches.


Critical Success Factors

1. Formulation & Product Development

  • Schedule and execute development activities as per the Quality Target Product Profile (QTPP).

  • Select suitable polymers/excipients based on functional properties and scientific rationale.

  • Evaluate Critical Quality Attributes (CQAs) of drug/excipients and assess implications for product development.

  • Design reproducible, scalable, cost-effective, and environmentally friendly processes with higher yields.

2. Design of Experiments (DOE)

  • Execute experiments using DOE approaches to optimize product and process parameters.

3. Pharmaceutical Development Report (PDR)

  • Prepare PDR in alignment with Common Technical Document (CTD) Module 3 requirements.

  • Ensure compliance with regulatory requirements defined in QTPP.

4. Project Management

  • Plan, manage, and prioritize multiple projects to meet defined delivery goals within timelines.


Education & Experience

  • Qualification: M.Pharm / Ph.D. in Pharmaceutics or related discipline.

  • Experience: 5–7 years of experience in formulation and product development.