Experience:
- Bachelor's degree in chemistry, chemical engineering, or related field.
- Masters in Ayurvedic Medicine / Herbal Science / Pharmaceutical Sciences / Organic Chemistry or equivalent.
- 7-10 years in Ayurvedic formulation development, R&D, and regulatory compliance. Expertise in herbal product innovation and commercialization is preferred.
Job Summary:
- Lead end-to-end formulation development for cough syrups, tablets, lozenges, antacids and herbal supplements under Nivaran90.
- Manage trial and iteration-based product development, ensuring formulation stability, efficacy, quality, safety and compliance.
- Develop and maintain comprehensive regulatory documentation for AYUSH, FSSAI, GMP, and FDA approvals.
- Ensure that all R&D and production labs are certified and compliant with regulatory requirements.
- Oversee prototyping, testing, and commercialization of formulations, ensuring timely product launches.
- Scale up formulations for manufacturing including preparing product development reports and supporting quality documentation & regulatory submissions.
- Collaborate with cross-functional teams including marketing, sales, manufacturing, and quality assurance to drive innovation and product success.
Industry Knowledge:
- Ayurvedic and nutraceutical product formulation expertise.
- Knowledge of regulatory guidelines (AYUSH, FSSAI, FDA, GMP).
- Expertise in trial-based formulation management and iterative product development.
- Experience in managing regulatory documentation, lab certifications, and compliance.
- Experience in clinical trials and safety studies.
- Strong technical writing and documentation skills.
- Cross-functional collaboration with marketing, sales, and regulatory teams.
Behavioral Competencies:
- Innovativeness
- Strategic Thinking
- Efficiency Orientation
- Project Management
- Analytical Skills
- Concern For Standards
- Results Orientation
- Thoroughness
Requirements
ROLES & RESPONSIBILITIES
Product Formulation & Development
- Develop, test, and optimize Ayurvedic formulations for cough syrups, lozenges, tablets, and antacids.
- Implement trial-based formulation strategies, optimization, and scale-up from lab to commercial production while ensuring that all products undergo multiple rounds of iteration for stability, efficacy, and consumer acceptance.
- Maintain detailed records of all formulation trials, adjustments, and outcomes, ensuring full traceability.
- Conduct comparative analysis with competitor products to identify differentiation and efficacy improvements.
- Collaborate with the procurement and quality teams to source authentic herbal raw materials.
- Conduct analytical testing to ensure quality and perform stability studies to determine shelf life and storage conditions
Regulatory Compliance & Documentation
- Ensure all formulations comply with all national and international regulations applicable to Ayurvedic products.
- Prepare and maintain detailed regulatory documentation for AYUSH, FSSAI, GMP, and FDA approvals and audits.
- Develop Standard Operating Procedures (SOPs) for formulation, testing, and production processes.
- Maintain up-to-date Material Safety Data Sheets (MSDS), Certificate of Analysis (COA), Stability Testing Reports and licensing documentation.
- Work with external testing labs, Contract Research Organizations (CROs), and regulatory agencies for approvals.
Lab Certification & Validation
- Ensure that all R&D and manufacturing labs are certified by relevant regulatory authorities and meet Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP) standards.
- Conduct periodic lab audits to ensure compliance with safety, hygiene, and regulatory requirements.
- Coordinate with third-party laboratories for external validation, quality checks, and certifications.
Prototyping & Scale-Up Process
- Develop and refine product prototypes, conducting extensive stability and efficacy studies.
- Work closely with production teams to ensure smooth technology transfer from lab-scale to full-scale manufacturing.
- Conduct pilot batch trials and ensure that manufacturing processes align with product specifications.
- Address and troubleshoot any process challenges during scale-up.
Clinical Research & Efficacy Validation
- Design and oversee clinical and consumer trials to validate product claims.
- Collaborate with Contract Research Organizations (CROs) and research institutions to execute studies on safety, efficacy, and therapeutic benefits.
- Ensure timely completion of all clinical trials and documentation for regulatory submissions.
- Develop scientific rationales for marketing and medico-legal purposes.
Cross-functional Collaboration
- Provide technical support to marketing and sales teams for product promotions and consumer education.
- Develop training materials and conduct training sessions for internal teams on product science and regulatory aspects.
People Development
- Nurture people and develop their functional / technical competencies. Plan performance of the team, guide them, monitor, review and provide feedback
- Counsel, guide and build the team equipping them to excel in their goals and product development / improvements.