Job Description

Company DescriptionDr. 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 Summary
We are seeking a dynamic and experienced Formulation Scientist in Injectable division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer.Roles & Responsibilities

• You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval of Complex Injectables (Liposomes, Peptides, Lyophilized injectable etc.).
• You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections and 505(b)(2) injectable products.
• You will be responsible to support in scale-up to pilot/plant scales for Injectable Products.
• You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions.
• You will be responsible for technology transfer and execution of the batches.
• You will be responsible for performing pre-formulation studies, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up) with advanced techniques including - Cryo-Tem, DSC, NMR, CD, SEC-MALS.
• You will be involved in design and execution of In-vitro and In-vivo animal studies for 505(b)(2) products.
• You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development.
• You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements.

QualificationsEducational qualification: Masters in PharmaceuticalMinimum work experience: 3 to 5 years of experience in pharmaceutical company in Injectable products.Skills & attributes:
Technical Skills

• Have work experience on Formulation Development and expertise in inhalation/injectable dosage form.
• Experience in areas of product development for Generic Injectable
• Experience in Quality by Design (QbD).
• Experience in Process Optimization and scale up.
• Experience in Operational Excellence.
• Knowledge on Good Manufacturing Practice and Good Laboratory Practice.
• Experience in Technology Transfer.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.

Additional InformationAbout the DepartmentIntegrated Product Development OrganisationWe 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/#!/

Dr. Reddy's Laboratories