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Analytical Project Manager

  1. Biologics
  2. Hyderabad
  3. Biopharmaceutics & Bio Analytical

Company Description

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 Description

Job Summary

We are seeking a Analytical Project Manager to lead regulated bioanalysis of large molecules, including monoclonal antibodies and fusion proteins. The role involves supervising method development, qualification/validation, and sample analysis for multiple assets, with expertise in ligand binding assays, MSD, ELISA, and protein conjugation. Incumbent should be able to 

  • Supervise method development, method qualification and sample analysis for 2-3 assets in regulated bioanalysis of Pharmacokinetics, immunogenicity and pharmacodynamics for large molecules (monoclonal antibodies and fusion proteins)

  • Should have in depth knowledge of Ligand binding assays, MSD, ELISA, Conjugation of proteins.

  • Author and review Method development, Qualification/validation,  sample analysis reports and  clinical study related documents

  • Should have knowledge and experience of regulatory requirements of FDA, EMA, ANVISA, CDSCO guidelines

  • Should have proficiency in LIMS software, MSD, Softmax pro is needed


Qualifications

MSc/M.tech with 10-15  years of experience or Ph.D with 5-7 years of experience

Self Starter, Highly motivated Scientist, excellent written and oral skills


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