Team Member - ASAT

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 methodrelated 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 methodrelated 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. 

Qualifications :

Educational qualification: Post Graduation in Pharma/Physics 

Minimum work experience: 810 years of experience 

Skills & attributes:
Technical Skills

• Able to understand the mass spectrometry principles and Liquid chromatography principles.
• Good handson experience on Liquid chromatographymass spectrometry (LCMS) Tandem mass spectrometry (MS/MS) and High resolution mass spectrometry (HRMS) 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 problemsolving abilities.
• Leadership skills to motivate and mentor the team.

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused 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 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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

Remote Work :

No

Employment Type :

Fulltime