Analytical Scientist Injectable

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

• You will be responsible Analytical method development and validation of injectable products.
• You will be responsible to perform the Drug Master File/Literature review and procure the relevant columns and standards in order to initiate the analytical method development. Stay updated with the latest literature and industry developments in the field.
• 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 execute analytical activities as per defined procedures, document the data and send the respective record of analysis to group leader/analytical expert for the review and release in order to provide the approved results to formulation team.
• You will be responsible for analytical method development for drug products for various tests mentioned in the specification in order to analyse the product development batches for the prototype screening.
• You will be responsible for analytical method validation activities at the manufacturing sites providing method development reports to verify the validation parameters and ensure the execution of method validation as per the regulatory requirement in order to provide the authentic analytical validation report for the regulatory filing.
• You will be responsible for analytical method transfer to plant locations successfully in order to train the Quality Control (QC) team on the methods for the Exhibit and commercial batch analysis at plant.
• 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.
  

Qualifications

Educational qualification:

Minimum work experience:

Skills & attributes:

Technical Skills

• Extensive work experience in analytical method development and validation of injectable products.
• Proven experience with injectable, ophthalmic, peptide, and suspension products.
• Demonstrated expertise in sameness and characterization studies for complex molecules.
• Proficient understanding of various analytical techniques including HPLC, GC, UV, FTIR, KF, and mass spectrometry.
• Advanced skills in troubleshooting analytical methods and instruments.
• Comprehensive understanding of Abbreviated New Drug Application (ANDA) filing requirements.
• Strong knowledge of regulatory guidelines and industry standards related to pharmaceutical product development and analysis.
• Proven experience in method development, validation, transfer, and documentation in compliance with regulatory requirements.
• Familiarity with Quality by Design (QbD) principles and their application in analytical method development.
• Experience with stability testing and forced degradation studies for injectable products.
• Knowledge of current Good Manufacturing Practices (cGMP) and ICH guidelines.

Behavioral Skills

• Strong analytical and problem-solving abilities, with a keen attention to detail
• Excellent communication and interpersonal skills, with the ability to effectively present complex analytical data to diverse audiences..
• Ability to work collaboratively with own team and cross-functional teams in a fast-paced environment.
• Demonstrated project management skills and ability to handle multiple projects simultaneously.
• Adaptability and willingness to learn new techniques and methodologies.
• Strong commitment to safety protocols and environmental regulations in laboratory settings.

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered