Job Description

Company DescriptionDr. 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 seeking a dynamic and experienced Scientist in Bioassay of injectables to design and develop robust in vitro bioassay methods for peptide and small molecules and for biological characterization of Active Pharmaceutical Ingredient (API) and Finished products (FP) in generic drug development.Roles & Responsibilities

• You will be responsible for comprehensive literature searches and strict adherence to guidelines for designing safety and efficacy/potency bioassays crucial for product development.
• You will be responsible to design & execute experiments with relevant documentation based on clear understanding of relevant Quality by Design (QbD) elements. Collect and interpret data from experiments conducted (cell based/biochemical/ELISA/binding assays) and interact with relevant experts to gain basic understanding of design and development considerations for successful technology transfer.
• You will be responsible to conduct method development and qualification and actively participate in tech transfer for validation of methods to QC sites. Ensure alignment with laboratory results and contribute to documentation for gate clearances.
• You will be responsible to test assigned samples and release data within defined timelines for developmental and laboratory batches..
• You will be responsible to prepare and compile regulatory documents, including protocols and reports, for filing and deficiency response requirements. Conduct stage-wise drafting of documents in accordance with regulatory guidance.
• You will be responsible to maintain impeccable documentation practices, adhering to good documentation principles. Develop Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), study reports, and other essential documents. Create comprehensive method development and validation protocols and reports.
• Cultivate scientific acumen and foster an innovation culture through rigorous study of scientific literature. Remain at the forefront of developments in the field and identify opportunities to apply new knowledge in consultation with subject matter experts.

QualificationsEducational qualification: MSc (Biotechnology/Biology) / M Pharm/M tech/ PhD.Minimum work experience: 3-7 years of relevant industrial experience in in vitro bioassay methods, cell based and biochemical assays and mammalian cell culture
Skills & attributes:
Technical Skills

• Hands on experience in Mammalian cell culture techniques and safety measures; cell banking and characterization.
• Ability to develop and validate in vitro bioassay method for small molecules and peptides to support biocharacterization of the product. Having experience of development and validation of 2 or more peptide/large molecule products will be of added advantage.
• Knowledge on cGMP and QMS will be a plus
• Exposure and proficiency in multiple bioassay techniques like ELISA/Binding assay/viability studies/complement assays/SPR/ colorimetric assays /FRET /Luminescence assays
• Familiar with usage of instruments like spectramax for assay development and data analysis softwares like Graphpad Prism and PLA3
• Keeping abreast of current developments and new techniques in the field of molecular biology, cell biology and generic drug development..
• Strong knowledge of pharmaceutical generic drug development and familiar with regulatory requirements and guidelines for biological assays.
• Awareness of Good Manufacturing Practice (GMP) guidelines, Standard Operating Procedures (SOPs) and internal systems related to own tasks & applies the same in daily operations effectively

• Behavioral Skills
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams.
• Excellent documentation practices and meticulous attention to detail.
• Willingness to take initiative where required and work proactively to achieve team goals.

Additional InformationAbout the DepartmentIntegrated Product Development OrganisationWe integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused 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 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.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/#!/

Dr. Reddy's Laboratories