Senior Research Scientist
Job Description
Job Title:
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