Job Description

Senior Research Scientist

Location/Site : I&D, Mumbai

Department/Division/ Unit : Formulation Development- Topical Semisolid dosage forms- Pharmaceutical and Cosmeceutical Innovation

Educational Qualification M. Pharm (Pharmaceutics)

Total Work Experience 10 + years

JOB DUTIES/ RESPONSIBILITIES/ ACCOUNTABILITIES :

• Lead formulation development of topical dosage forms (Creams, Ointments, Gels, Lotions, etc.), including design of proof of concept formulations, prototype development, stability studies, and technology transfer activities.
• Drive end-to-end product development lifecycle from concept to commercialization, ensuring alignment with global regulatory requirements (including markets beyond India such as US, EU, and other international regions).
• Provide technical mentorship to junior scientists and team members; guide problem-solving, experimental design, and capability building within the team.
• Collaborate with cross-functional stakeholders (Regulatory, QA, Production, Supply Chain, Marketing) to ensure seamless execution of development, validation, and commercial manufacturing.
• Author and review technical and regulatory documentation, including Product Development Reports, Quality Overall Summary (QOS), and submission dossiers for National and international filings.
• Lead scale-up, process optimization, and technology transfer to manufacturing sites, ensuring robust and reproducible processes that meet global quality and compliance standards.
• Apply Quality by Design (QbD) principles for formulation and process optimization to enhance product performance and lifecycle management.
• Ensure compliance with GMP, SOPs, and global regulatory expectations, including review of batch records, validation reports, investigation reports, and process characterization data.
• Drive continuous improvement initiatives, including reformulation for cost optimization, quality enhancement, and market competitiveness across multiple geographies.
• Support equipment selection, qualification, and laboratory excellence, ensuring best practices in R&D operations.
• Take ownership of global product strategy execution, ensuring readiness for multi-country launches and lifecycle management.

Key Accountability

• Mentoring responsibility to trainees and Junior team members
• Global (non-India) product development
• Strategic and cross-functional ownership
• Strong regulatory & international filing focus
• Greater accountability in commercialization