Position: Head of Research and Development (R&D) Location: Rajkot Job Overview: The Head of Research and Development (R&D) will be responsible for leading and overseeing the R&D department to drive the development of innovative, cost-effective, and safe technologies for the synthesis of Active Pharmaceutical Ingredients (APIs) and intermediates. This position demands expertise in the scale-up and technology transfer processes, as well as comprehensive regulatory knowledge, with a focus on ensuring compliance with international standards for pharmaceutical product development. Key Responsibilities 1. Leadership & Team Management o Lead and manage a team of chemists, ensuring efficient collaboration across R&D, tech transfer, and production teams. o Oversee the development of innovative and eco-friendly synthetic processes for APIs and intermediates. o Provide guidance and mentorship to R&D staff and encourage professional development . 2. Process Development & Technology Transfer o Lead the development of reliable, cost-effective, non-infringing, and environmentally sustainable technologies for API synthesis. o Prepare and review comprehensive Process Development Reports (PDRs) and Technology Transfer Documents (TTDs) for the smooth transition of technologies to production units. o Ensure effective scale-up of laboratory processes to manufacturing-scale operations while adhering to regulatory requirements. 3. Regulatory & Compliance o Oversee data generation for U.S. and European DMF filings, ensuring accuracy and compliance with regulatory guidelines. o Respond to regulatory queries and customer concerns related to product development, DMF filings, and quality control. o Monitor and ensure compliance with regulatory standards, including genotoxic, nitrosamine, and elemental impurity assessments for molecules. o Maintain thorough understanding and application of regulatory guidelines and standards for API development. 4. Product Development & Evaluation o Lead the development of new API molecules, ensuring innovative, non-infringing synthetic routes. o Conduct detailed literature surveys and patent infringement analyses to design non-infringing synthetic routes for new products. o Supervise and support the analytical testing of raw materials, in-process intermediates, and finished products . 5. Analytical Expertise o Apply advanced techniques for the interpretation of NMR, Mass Spectra, CHN, LCMS, GCMS, IR, GC, HPLC, XRD, DSC, and other analytical techniques. o Establish and optimize testing procedures for assessing raw materials, intermediates, and final product quality. o Provide expertise in the evaluation of analytical data and troubleshooting of complex R&D issues. 6. Innovation & Continuous Improvement o Foster a culture of innovation within the R&D team to identify and develop new API molecules and advanced technologies. o Ensure that all research is conducted in alignment with current scientific trends and market needs. o Strive for continual improvement in R&D processes, methodologies, and product quality Key Skills and Competencies : • Expertise in organic chemistry, particularly in the synthesis and development of APIs and intermediates. • Proficiency in analytical techniques including NMR, Mass Spectra, CHN, LCMS, GCMS, IR, GC, HPLC, XRD, DSC, and more. • Strong understanding of regulatory requirements and guidelines (US, Europe, etc.) related to DMF filings, product development, and quality control. • Problem-solving skills with the ability to evaluate and resolve complex R&D and process-related issues. • Knowledge in literature search, patent infringement analysis, and non-infringing process development. • Expertise in quality by design, genotoxicity assessments, and nitrosamine risk assessments. • Strong leadership and team management skills, with experience in tech transfer to manufacturing scale Qualifications : • Educational Qualification: M.Sc. or Ph.D. in Organic Chemistry. • Experience: Minimum 10+ years of experience in Research and Development, with a proven track record in developing APIs and intermediates and leading successful R&D teams. • Regulatory Knowledge: In-depth knowledge of DMF filing processes, USFDA, EMA regulations, and global regulatory frameworks for API development. • Industry Experience: Experience in the pharmaceutical industry, specifically in API synthesis, process scale-up, and technology transfer. . Preferred Skills: Experience with regulatory submissions for new products and API filings. Familiarity with GxP standards and other relevant industry certifications. .Strong publication record in the field of organic chemistry and pharmaceutical research.
