Process Development Specialist
1 week ago
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 transparencyDr 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 SummaryWe are seeking a dynamic and experienced Specialist in Process Development in the pharmaceutical development process, responsible for strategy evaluations, process design, optimization, scale-up calculations, and handling exhibit batches. This role involves working on oral solid formulations and technical documentation, as well as process validations, to ensure the successful development and scale-up of pharmaceutical products.Roles & Responsibilities You will be responsible to Conduct strategy evaluations to design and optimize pharmaceutical processes, ensuring efficient and cost-effective development using Continuous Manufacturing.You will be responsible to Calculate batch sizes for both early development and commercial production, considering critical parameters and quality standards.You will be responsible to Lead process development activities for API synthesis using Flow synthesis, from concept to commercialization, including the design of experiments and formulation strategies.You will be responsible to Perform scale-up calculations and execute scale-up processes to ensure successful transition from lab-scale to production-scale.You will be responsible to Handle exhibit batches, coordinating activities and documentation to meet regulatory requirements and project timelines for Flow pipeline projects.You will be responsible to Prepare and maintain technical documentation, including development reports, process validation protocols, and regulatory filings.You will be responsible to Collaborate with cross-functional teams to drive process improvements, troubleshoot issues, and ensure product quality and consistency.You will be responsible to Stay updated with industry trends and regulatory guidelines, incorporating best practices and innovative technologies into the Flow development process. Qualifications Educational qualification: Masters in pharma/Biotechnology/ChemistryMinimum work experience: 12+ years of Experience in Process Development/ManufacturingSkills & attributes:Technical Skills Experience in process optimization, development and troubleshooting in relevant dosage forms or technologies Hands-on experience in end-to-end scale upDepth understanding of process techniques & equipment knowledge Knowledge on Deficiency management and product validations.Experience in manufacturing process improvement.Experience with Flow chemistry and Continuous Manufacturing Behavioral SkillsExcellent communication and interpersonal skills.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. Additional Information About the DepartmentIntegrated 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 OfferedAt 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 CultureAsk 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
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