Analytical Scientist Active Pharmaceutical Ingredient (API) AR&D

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 Summary
We are seeking a highly skilled Analytical Scientist to join our Research and Development team. The successful candidate will be responsible for developing, validating, and implementing analytical methods for the quantification and identification of genotoxic impurities in pharmaceutical products. This role will involve extensive use of chromatography techniques and adherence to regulatory standards. The ideal candidate should have a strong background in analytical chemistry, method development, and data analysis, with a keen eye for detail and a commitment to ensuring the highest quality standards.

Roles & Responsibilities

• You will be responsible to review relevant Literature and stay updated with the latest research and scientific literature relevant to the field of genotoxic impurities and chromatography methods.
• You will be responsible to develop and optimize chromatography-based methods for accurately quantifying genotoxic impurities in various samples.
• You will be responsible to address regulatory deficiency queries concerning the analytical methods and data related to genotoxic impurities.
• You will be responsible to ensure the quality and accuracy of reference standards and working standards used in analytical testing and method development.
• You will be responsible to develop analytical methods, conduct validation studies to ensure the accuracy and reliability of the methods, and transfer validated methods to the Quality Control (QC) department.
• You will be responsible to prepare comprehensive reports documenting method development, validation results, and any forced degradation studies performed.
• You will be responsible to conduct forced degradation studies to identify potential impurities and establish their chemical nature and behaviour.
• You will be responsible to perform real-time analysis of samples during product development stages to ensure product quality and consistency.
• You will be responsible for compilation of Stability Data to assess the stability profile of the products under various conditions.
• You will be responsible to evaluate the effectiveness of the product development strategy and identify any cross-functional issues affecting the process.
• You will be responsible to identify and plan for the developmental needs of the product, considering factors such as scale-up and potential process improvements.
• You will be responsible to source and manage the procurement of necessary chemicals, solvents, columns, and other laboratory equipment.
• You will be responsible to ensure proper maintenance of laboratory equipment as per Good Laboratory Practices (GLP) standards to guarantee accurate and reliable results.
• You will be responsible to calibrate instruments as per the calibration schedule and strictly follow Standard Operating Procedures (SOPs) to maintain consistency and accuracy.
• You will be responsible to maintain a clean and organized work area, and ensure that the laboratory environment is controlled at the required temperature for optimal analytical conditions.
• You will be responsible to keep all relevant documents well-maintained and organized for easy access and compliance with internal and external auditing requirements. 

Educational qualification: Masters in Science/ Organic chemistry

Minimum work experience: 5 years of experience in analytical method development

Skills & attributes: 
Technical Skills

• Have work experience on Process scale up of Active Pharmaceutical Ingredients.
• Experience in Process Optimization (Manufacturing)
• Experience in the development and regular analysis in Wet analysis-IR, Ultra Violet, Moisture analysis, Chromatographic techniques
• Strong understanding of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.
• Proven experience in method validation and documentation in compliance with regulatory requirements.
• Working knowledge in HPLC/UHPLC/ GC is mandate
• Working knowledge in peptide characterization and analysis is preferable.
• Handling of SEC-MALS, Edman sequencer, capillary electrophoresis, Circular dichroism is preferable.

Behavioral Skills

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

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/#!/