Team Member - ASAT

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 an experienced Analytical Specialist specializing in Mass Spectrometry to develop sensitive and robust methods for quantifying genotoxic impurities in drug substances and products. This role involves method development, validation, troubleshooting, and resolving method-related issues. Your expertise in Mass Spectrometry will be crucial in creating accurate impurity profiles through comprehensive analysis.

Roles & Responsibilities

• You will be responsible for developing sensitive and robust methods to quantify genotoxic impurities in drug substance and products. This involves selecting appropriate quantitation modes, validating methods, and transferring them to QC sites. Your role includes troubleshooting and resolving method-related queries and issues, ensuring quality robust method development.
• You will be responsible for identifying impurities in stress and stability studies, correlating data based on Mass and fragmentation, and developing methods for screening leachables in Parental formulations. The goal is to create accurate impurity profiles through comprehensive analysis.
• You will respond to regulatory deficiencies related to Mass spec techniques, provide quantitation support for plant samples, and perform structure confirmation activities for working/reference standards and impurities. Anticipating potential queries from regulatory authorities/customers and proposing relevant measures for timely responses are crucial aspects of this role.
• You will be responsible for training new team members, preparing Standard operating procedure (SOPs) and guidelines, conducting incident/investigation analysis, identifying Corrective Action Preventive Action (CAPA) and root causes, and ensuring adherence to safe work practices. Maintaining Good Manufacturing practices (GMP) in laboratory and conducting preventive maintenance of instruments are essential for meeting minimum operating standards. 

Educational qualification: Post Graduation in Pharma/Physics 

Minimum work experience: 8-10 years of experience 

Skills & attributes:
Technical Skills

• Able to understand the mass spectrometry principles and Liquid chromatography principles. 
• Good hands-on experience on Liquid chromatography-mass spectrometry (LC_MS), Tandem mass spectrometry (MS/MS) and High resolution mass spectrometry (HR-MS) techniques.
• Excellent skill set on method development, sample preparation, matrix interference removal and validation of quantitative methods in API and formulations.
• Experience on extractable and leachable, analytical method development, validations & transfers.
• Good documentation practices and laboratory practices.
• Sound knowledge and understanding of FDA regulations governing pharmaceuticals. 

Behavioral Skills

• Excellent communication and interpersonal skills.
• Ability to work with cross functional teams.
• Strong analytical and problem-solving abilities.
• Leadership skills to motivate and mentor the team.

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/#!/