Dr Reddy's Laboratories Limited
pharmaceutical
QualityControlAssociate-Bioassay
Neural analysis suggests this role is
optimal for mid candidates.
“Quality Control Associate - Bioassay at Dr Reddy's Laboratories Limited. Skills: Bio-complexity assessment, Biopharmaceutical strategic support, cell-based bioassays, SPR technique, FACS techniques, cGMP, Good Documentation Practices (GDP). Bio-complexity assessment and provide inputs for product selection for United States, Europe, and Emerging markets. providing Biopharmaceutical based strategic support for assessing the feasibility and complexities of new product development”
What You'll Achieve.
successful market entry; reach over 1. 5 Bn+ patients across the world by 2030
Industry & Context.
conducting comprehensive gap analyses; addressing regulatory queries; Deficiency responses
What They're Looking For.
Must Have
M. Sc. , M. Tech. or B. Tech. in Microbiology, Biochemistry, or Biotechnology, 8-10 years of experience, understanding of the Biologicsiosimilar industry, including processes, regulations, and trends, Hands-on experience in cell-based bioassays, SPR technique, FACS techniques, knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioassay (BA) Labs, Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics, Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP), knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques, understanding about bioassay technology transfer, method validations & QMS, Prioritizes effective communication, demonstrates a performance-oriented mind-set, Effective verbal and written communication skills, Performance-oriented approach, consistently striving for high standards, Demonstrates flexibility in working shifts, a clear understanding of team dynamics
What You'll Do.
Bio-complexity assessment and provide inputs for product selection for United States
providing Biopharmaceutical based strategic support for assessing the feasibility and complexities of new product development
conducting comprehensive gap analyses
ensuring alignment with regulatory requirements for successful market entry
identification of bio relevantio discriminatory media/appropriate in-vitro tools based on Critical Material Attributes & Critical Quality Attributes for periodical Management reviews
support in designing & guiding the team in modeling and simulation of available data using data Analytical Tools and Software
risk assessment for granting approval for pilot bio studies and early bio-manufacturing through Best Available Technologies (BAT) meetings and phase gates
managing the team and provide them the guidance and support in setting up their goals
addressing regulatory queries
Deficiency responses and guiding the Product Development Team
How You'll Work.
Team & Collaboration
managing the team and provide them the guidance and support in setting up their goals; guiding the Product Development Team; fostering teamwork and shared success
Communication Scope
Effective verbal and written communication skills
Process & Methodology
managing the team, setting up their goals
Full Job 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. * You will be responsible for Bio-complexity assessment and provide input
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