Specialist- Process MSAT at Dr Reddy's Laboratories Limited

Visakhapatnam, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

26 Jan, 26

Salary

0.0

Posted On

28 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Injectables, Technology Transfers, Six Sigma, Lean Techniques, Good Documentation Practices, Good Manufacturing Practice, Communication Skills, Interpersonal Skills, Analytical Skills, Problem-Solving Skills, Collaboration, Quality By Design, Process Development, Troubleshooting, Continuous Improvement, Talent 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 Job Summary We are seeking a dynamic and experienced Team Lead in Process Development to lead and guide the Injectable Process development team in areas of Quality by Design (QbD), Process selection, Scale Up and Technology transfer to Manufacturing, Science & Technologies (MSAT)/ Formulation Technology Organisation (FTO)/ Contract Manufacturing Organisation (CMO) and ensure product development leads to development of robust manufacturing process throughout the clinical phases and commercial product life cycle Roles & Responsibilities Technology Transfer, Troubleshooting & Continuous Improvement Prepare, review, and approve technical protocols, reports, SOPs, and product impact assessments related to product lifecycle management (LCM). Initiate, review, and approve change controls, incidents, and risk assessments related to validation and qualification activities. Coordinate with cross-functional teams (Production, QA, QC) for execution and documentation of new products, scale-ups, and transfers. Lead technology transfer activities for new products, scale-ups, line transfers, and site-to-site commercial batches for injectable products. Support investigations for non-conformances (Incidents, OOS, OOT, Market Complaints) through root cause analysis and impact assessments. Provide technical support for process changes and improvements along with addressing regulatory deficiencies and support audits to ensure timely product approvals. Serve as a technical expert to resolve domain-specific issues and contribute to organizational problem-solving. Review Continued Process Verification (CPV) assessments and Product Quality Reports (PQRs). Cleaning Validation: Prepare and review cleaning validation documents including protocols, reports, master plans, and assessments. Analytical Support: Provide technical support to the analytical team in designing and reviewing analytical methods for quality and compliance. Evaluate and introduce new analytical technologies to resolve technical issues, perform proof of concept, and support HPT initiatives. Subject Matter Expertise: Serve as the subject matter expert for fill-finish processes, ensuring robust and compliant operations. Knowledge Sharing & Talent Development Facilitate knowledge sharing through discussions, training sessions, and invited talks to build analytical competence. Support talent acquisition and induction processes to ensure recruitment of qualified personnel. Qualifications Educational qualification- Master in Pharma/ Ph.D in Pharma Minimum work experience- 10-12 years of Experience and at least 6 years of experience in Drug product tech transfers & operations support (DP-MSAT) Skills & attributes – Technical Skills- • Handled various forms of injectables which includes dry powders, lyo products and liquid injections. • Knowledge of the technology transfers from site to site and R&D to operations. • Knowledge in Six Sigma Lean Techniques • Knowledge about Good Documentation practices (GDP) and Good Manufacturing Practice (GMP). Behavioural Skills- • Excellent communication and interpersonal skills. • Strong analytical and problem-solving abilities. • Ability to work collaboratively with own team 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 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/#!/

Responsibilities

Lead and guide the Injectable Process development team in areas of Quality by Design, Process selection, Scale Up, and Technology transfer to Manufacturing. Ensure product development leads to robust manufacturing processes throughout the clinical phases and commercial product life cycle.