Analytical Scientist Active Pharmaceutical Ingredient API ARD

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 chromatographybased 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 realtime 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 crossfunctional issues affecting the process.
• You will be responsible to identify and plan for the developmental needs of the product considering factors such as scaleup 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 wellmaintained and organized for easy access and compliance with internal and external auditing requirements. 

Qualifications :

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 analysisIR 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 SECMALS Edman sequencer capillary electrophoresis Circular dichroism is preferable.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problemsolving abilities.
• Ability to work collaboratively with own team and crossfunctional teams. 

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