Tech Lead

Tech Lead - Injectable Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait. We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). 'The Next and the New' is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy's maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization. Job Description Job Summary We are seeking a dynamic and experienced Lead in Process Development provide technical leadership in ideating, strategizing and developing novel formulations to build differentiated product portfolio for serving unmet needs of patients. Ensuring successful establishment of proof of concept through Bioequivalence / Bioavailability studies (BA/BE) or Clinical route, scale-up and exhibit batches, preparation of filing documents and strengthening technical capability and internal systems related to the function.Roles & Responsibilities You will be responsible to ensure the development of robust, effective, and differentiated drug products that adhere to safety and quality standards. Utilizing pharmacokinetic and clinical understandings, guiding team members, and facilitating effective risk evaluation and mitigation throughout the product development process. You will be responsible to Integrate all inputs from functional experts to develop regulatory strategy and pathway. Participate and guide the team to review regulatory documents for submission to Regulatory Affair agencies. You will be providing support internally as subject matter expert to identify opportunities for strengthening Intellectual Property (IP) of the organization. Identify areas to develop internal formulation development guidelines to identify and develop capabilities that enable future complex differentiated product development. You will be responsible for providing technical guidance through scientific discussions and knowledge-sharing within the team. Also evaluating individual team members' areas of improvement, and coaching and mentoring them to enhance their capabilities. You will be responsible for ensuring implementation of internal systems of project management to facilitate Cross Functional Team (CFT) understanding of the project to assist flawless and timely delivery of project. You will be responsible to identify areas of technical improvement in product development including clinical and pharmacokinetic understanding, facility building, implementing Quality by Design (QbD) /Design of Engineering (DoE) principles. You will be responsible for budgeting, monitor cost of the project and maintain cost effectiveness. Qualifications Educational qualification- Masters/Ph.D in pharmaMinimum work experience- 7-10 years of experience in Formulation development Skills & attributes – Technical Skills- In-depth knowledge in novel/complex drug delivery systems with sound technical competence over various platform technologies. Understanding the regulatory aspects in the domain of generic and new product development. Developed at least one complex/differentiated product and have delivered >5 products overall. Experience in New product ideation and Evaluation. Experience of product development and Technology transfer for global markets. In-depth understanding of pharmacokinetic and pharmacodynamics response relationship between animals and human. Complete understanding on prerequisites of preclinical/clinical studies, sourcing, analytical data interpretation and regulatory aspects Intellectual Property (IP) laws and patents; developmental quality aspects. Behavioral Skills- Excellent communication and interpersonal skills. Business Acumen & Decision Making Strong analytical and problem-solving abilities. Performance oriented and good at building, leveraging relationship. Ability to work collaboratively with own team and cross-functional teams. Committed to Learning & Coaching the team. Additional Information About 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 dosages Our 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 Experience LevelSenior Level