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 transparencyDr 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 looking for an Analytical Expert to perform and oversee analytical activities for Biologics/Biosimilar projects. This includes overseeing method validation, methods transfers, gap analysis, troubleshooting, investigations, annual method performance and data trending, and ensuring documentation and data compilation adhere to regulatory norms. The ideal candidate will bring expertise in analytical sciences and a strong understanding of regulatory requirements to ensure the success of projects.
Roles & Responsibilities
- Working under ASAT Team to adhere with various GxP procedures, guidance and Quality Management Systems (incl. CCs, CAPA).
- Be a Subject Matter of Expert in Analytical Sciences and Technology function.To be a SME for physico chemical methods (HPLC, CESDS, cIEF etc.) or molecular biology (HCP, HcDNA, LPA etc.) and or Bioassay.
- Internal and external method transfer activities, including method reviews & gap analysis and possible mitigations.
- Life cycle Management of analytical methods (review of method performance + analytical aspects of CPV and APQR).
- Investigations, Root cause analysis, Gap Assessment, CAPA implementation, Action evaluation and Effectiveness check.
- Regulatory Requirements including Internal or External audits, Audit readiness and Query response drafting.
- Method Validation and Internal Tech Transfer reviews.
- Alternate vendor support – writing protocols and reports
- Having experience in extended characterization analysis would be an added advantage (ex: LC MS) and other physico chemical methods.
- Drug product Particle characterization and container closure integrity test experience would be an added advantage.
Qualifications
Educational qualification
: B.Pham., M.Pharm., M.Sc or PhD.
Minimum work experience:
6 to 12 years
Skills & attributes:Technical Skills
- A comprehensive understanding of the biopharmaceutical industry, including its dynamics, regulations, and market trends.
- Hands-on experience and proficiency in conducting High-Performance Liquid Chromatography (HPLC) or Molecular biology or Bioassay techniques, which are the key techniques for separating, identifying, and quantifying components in a pharmaceutical sample.
- Expertise in performing method validation and method transfer, ensuring accuracy, precision, and reliability.
Behavioural Skills
- Displays the ability to perform tasks independently showcasing self-reliance and autonomy.
- Possesses strong writing skills, essential for drafting SOPs and protocols effectively.
- Demonstrates effective communication skills in obtaining approvals for SOPs and protocols.
- Cross functional collaboration is key aspect of this role.
Additional Information
About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structureRich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.
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/#!/
