Expert Characterization Technique

Job DescriptionJob Summary We are seeking dynamic and experienced Analytical Expert specializing in Extractable/Leachable studies, for guiding the team in executing smooth method development, validation and batch analysis of E&L methods using various techniques. Your role will involve providing critical inputs in designing the methods as per the regulatory requirement for Abbreviated New Drug Application (ANDA) and Drug Master Filing (DMF) filings. Additionally, you will collaborate with the AR&D lead to identify and implement process improvements within the existing analytical framework.Roles & Responsibilities You will be responsible to lead team in method development and validation for E&L studies.  Provide expertise in designing of methods, troubleshooting and data interpretation for GC-MS, LC-MS, ICP-MS and IC techniques. Guide preparation of technical reports and risk assessments, oversee leachable screening on various analytical platforms, and ensure alignment with business goals for robust and quality-driven product development You will be responsible to oversee formulation-related queries from regulatory authorities and customers, guiding teams in addressing deficiencies in all the techniques used. Proactively anticipate potential concerns, offering timely measures to address regulatory queries effectively. You will be responsible to assess and implement new technologies for project applications and regulatory compliance, developing proof of concept with expert support and fostering external collaborations. Evaluate technologies for streamlining existing methods, ensuring faster analysis and results to prepare the organization for future product portfolio challenges. You will be responsible to mentor and offer technical guidance to the Analytical Research & Development team, conducting periodic training to enhance their skills and performance. Implement tailored technical development plans to enrich the team's capabilities and expertise.  QualificationsEducational qualification: MS//Ph.D/ Master in PharmaceuticalMinimum work experience: 15-20 years of experience in Analytical Research and DevelopmentSkills & attributes: Technical Skills Experience in Extractable, leachable and elemental analysis. Knowledge on Extractable, leachable, The International Council for Harmonization (ICH) Q3D guidelines. Understanding and experience on Gas chromatography (GC) or high-performance liquid chromatography (HPLC) method development and method validations. Experience in analytical method development / validations / transfers/ investigations, sameness studies for elemental analysis.  Expertise on High-end techniques like LC-MS, GC-MS, ICP-MS and IC techniques Displays understanding of physical & chemical properties of materials used in formulations and applications. Behavioral Skills Excellent communication and interpersonal skills. Business Acumen and Good decision making skills. Ability to work with cross functional teams. Strong analytical and problem-solving abilities. Leadership skills to motivate and mentor the team.  Additional InformationAbout the Department Integrated Product Development Organisation                                          We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosagesOur product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.For more details, please visit our career website at