Quality Control Associate - Bioassay at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

09 Aug, 26

Salary

0.0

Posted On

11 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bioassay, Cell-based Bioassays, SPR Technique, FACS Techniques, Cell Culture, Electrophoresis, ELISA, PCR, cGMP, Good Documentation Practices, Protein Chemistry, Technology Transfer, Method Validations, QMS, Biologics, Biosimilars

Industry

Pharmaceutical Manufacturing

Description

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 You will be responsible for Bio-complexity assessment and provide inputs for product selection for United States, Europe, and Emerging markets. You will be responsible for providing Biopharmaceutical based strategic support for assessing the feasibility and complexities of new product development, conducting comprehensive gap analyses, and ensuring alignment with regulatory requirements for successful market entry. You will be responsible for identification of bio relevant/bio discriminatory media/appropriate in-vitro tools based on Critical Material Attributes & Critical Quality Attributes for periodical Management reviews. You will be responsible to support in designing & guiding the team in modeling and simulation of available data using data Analytical Tools and Software. You will be responsible for risk assessment for granting approval for pilot bio studies and early bio-manufacturing through Best Available Technologies (BAT) meetings and phase gates. You will be responsible for managing the team and provide them the guidance and support in setting up their goals. You will be addressing regulatory queries, Deficiency responses and guiding the Product Development Team. Qualifications Educational Qualification An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology Minimum Work Experience 8-10 years Skills & Attributes Technical Skills: Strong understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends. Hands-on experience in cell-based bioassays, SPR technique, FACS techniques. Strong 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). Strong knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques. Strong understanding about bioassay technology transfer, method validations & QMS Behavioural Skills: Prioritizes effective communication and 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 and a clear understanding of team dynamics. Additional Information 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/#!/" Job Family: Quality Sub Job Family: Quality Control Business unit: Biologics

Responsibilities

Responsible for bio-complexity assessments, strategic support for new product development, and ensuring regulatory alignment for market entry. Manages a team to set goals and handles regulatory queries and deficiency responses.