Team member - Sterile Operations at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

13 May, 26

Salary

0.0

Posted On

12 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Bio-complexity Assessment, Biopharmaceutical Strategic Support, Gap Analyses, Regulatory Requirements Alignment, In-vitro Tools Identification, Data Analytical Tools, Modeling and Simulation, Risk Assessment, Best Available Technologies (BAT), Team Management, Pharmacokinetics, Biopharmaceutics, Pharmaceutics, PKPD Modelling, IVIVC, Analytical Development

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 Roles & Responsibilities 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 Masters in Pharma/ PhD in Bio-pharmaceutics or pharmacokinetics or Pharmaceutics/pharmacology Minimum Work Experience 8-10 years of experience in Pharmacokinetics, Biopharmaceutics, and Pharmaceutics Skills & Attributes Technical Skills Strong understanding of differentiated and innovative product design the strategic path to make the product bio success. Deep Knowledge on formulation design and performance of products in-vitro & in-vivo. Exposure to Pharmacokinetic-Pharmacodynamics (PKPD) Modelling & Simulation. Knowledge of Preclinical and clinical Pharmacokinetic Modelling. Experience in in-vitro-in-vivo correlation (IVIVC) and Mathematical Compartmental Modelling. Knowledge on analytical development, clinical pharmacology, preclinical, regulatory understanding of regulated markets like United States, Europe, and Russia, China, India etc. Behavioural Skills Excellent communication, negotiation, and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with Regulatory and cross-functional teams. " Additional Information About the Department: Integrated Product Development Organisation We 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 for patients around the world. We have end-to-end capabilities in API, Formulations, Clinical, Intellectual Property, and Regulatory Affairs. Serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN, and all Emerging Markets, we offer innovative and generic products ranging from Active Pharmaceutical Ingredients (API), Oral Formulations, Parenteral (Injectables, Ophthalmics), and other dosages. Our product development efforts drive a portfolio of more than 1,000 products. Enabled by our robust R&D team consisting of over 200 scientists and functional experts, including more than 150 doctorates, we have filed 1,071 patents and published over 1,000 papers for peer review over the years. " Benefits Offered At Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. Our benefits are on par with the best industry standards and include: 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 also as a means to help patients lead healthier lives. 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: Manufacturing Sub Job Family: Production - General Preferred type of working: On-Premise Business unit: Biologics

Responsibilities

The role involves conducting bio-complexity assessments, providing biopharmaceutical strategic support for new product development feasibility, and identifying appropriate in-vitro tools based on material attributes. Responsibilities also include guiding data modeling, assessing risks for bio-studies, managing and guiding the team, and addressing regulatory queries.