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 Specialist in Formulation Development team responsible for execution and development of Oral Solid/Liquid formulations as per project timelines, ensuring successful pilot & pivotal bio study, robust scalable product development, support filing through approval of the product, coordinate and work closely with various CFTs like analytical team, SCM, process team, COE bio, CPPK, regulatory team, etc. during the course of development through approval. He or She shall work on differentiated formulations and develop them in-line with QbD principles with major focus on Emerging and India market reporting to the Tech lead Formulations. Roles & Responsibilities You will be responsible for discussion and planning strategies for product development, executing them and recording them in E-Lab notebook. Identify and proactively discuss potential challenges along with possible way forward. Collaborate and coordinate with analytical team for batch analysis followed by data analysis from time to time. Relevant documentations for license application and executions of pilot plant batches, stage gate clearances from time to time. Biweekly present project status to the delivery manager. Coordinate with process teams for optimization trials, plant presentations, preparation and review of plant documents and scale up the product from lab scale to exhibit scale/commercial scale. Support filing the product with PDR, support deficiency responses and submission of exhibit batch samples for pharmaceutical examinations/clinical studies, etc. Follow company systems and processes compliance to safety and quality. Qualifications Educational qualification: Masters/Ph.D in pharma Minimum work experience: 7 - 10 years of experience in Oral Dosage Formulations. Skills & attributes: Technical Skills Having worked on Differentiated Solid Oral Dosage Forms, platform technologies, hands on experience on modified release pellets and matrix formulations can be preferred. Hands on experience on lab scale and plant scale equipment's used in manufacturing of Oral solids and liquid formulations. Shouldering end-to-end responsibilities of product development team. Demonstrates data analytical and problem-solving skills. Know how on ICH guidance's, regulatory requirements for regulated and semi-regulated markets, cGMP and cGLP practices. Behavioral Skills Overall communication and presentation skills. Strong analytical and problem-solving abilities. Result oriented. Ability to work collaboratively with own team and cross-functional teams. Committed to continuous learning. 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 https://careers.drreddys.com/#!/ Show more Show less
