We are looking forynamic and experienced Formulation Scientist for Topical Product development for Global market.
Roles & Responsibilities
- Develop and optimize formulations using scientific principles to meet product specifications.
- Need to co-ordinate closely with analytical team for successful Proof of Concept (POC) , developing generic equivalent of Reference Listed Drug (RLD) for Topical products including Creams, Ointments, Gels, solutions etc.
- Review scientific data, evaluate prototypes, and support technical decision-making.
- Develop generic equivalents of RLD through formulation design, characterizationnd collaboration with cross-functional teams.
- Conduct comprehensive laboratory-scale batch manufacturing activities for formulation development and perform pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up).
- Drive formulation optimization, scale-up, batch execution at pilot and commercial scale.
- Coordinate API/raw material sourcing and ensure compliance with regulatory and internal requirements.
- Troubleshoot formulation issues and implement corrective actions to resolve technical challenges.
- Collaborate with quality assurance, manufacturing and regulatory teams to ensure compliance with industry standards and regulatory requirements.
- Prepare development, risk assessment, scale-up, and regulatory submission documents.
Educational Qualification
Masters degree in Pharmaceutics/Pharmaceutical Technology
Minimum Work Experience
2-6 years of experience in Topical Formulation Development
Skills & Attributes:
Technical skills
- Have work experience on Formulation Development and expertise in multiple topicalosage form for different markets like India and Russia.
- Experience in Quality by Design (QbD).
- Experience in Process Optimization and scale up.
- Knowledge on Good Manufacturing Practice and Valuable Laboratory Practice.
- Experience in Technology Transfer.
Behavioural Skills
- Strong communication and stakeholder management skills with the ability to convey technical information effectively.
- Excellent analytical mindset with proven problem-solving and decision-making capabilities.
- Demonstrateility to collaborate across cross-functional teams and drive projects to successful completion in a dynamic environment.