Team Lead - Projects - Biosimilars/ Biologics

  • Full-time
  • Job Family: Plant Engineering
  • Sub Job Family: Capital Projects
  • Preferred type of working: On-Premise
  • Business unit: Biologics

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.

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Job Description

Role Purpose

To lead the end-to-end execution of Biological Projects in Drug Substance (DS) manufacturing projects, including conceptual design, detailed engineering, procurement, construction, commissioning, qualification, validation support, and operational handover. The role is responsible for delivering projects safely, on schedule, within budget, and in compliance with global regulatory guidelines US, EU, WHO, PICS and cGMP requirements while supporting the organization's strategic growth objectives.

Key Responsibilities

  • Lead Greenfield, Brownfield and expansion projects for Drug Substance facilities.
  • Develop project execution strategies, project charters, schedules, budgets, and resource plans.
  • Ensure achievement of project milestones, cost targets, quality standards, and business objectives.
  • Drive cross-functional coordination among Engineering, Manufacturing, QA, Validation, Procurement, EHS, and Regulatory Affairs.
  • Provide periodic project status updates to senior leadership and steering committees.
  • Lead process design reviews and ensure compliance with process requirements.
  • Hands on experience on:
    • Process Equipment’s such as Bioreactors/Fermenters, Media & buffer preparation Systems, TFF System, UF System, Centrifuges, Chromatography System, Virus filtration System, Autoclave, Washers etc.
    • Process Flow Diagrams (PFDs)
    • Piping & Instrumentation Diagrams (P&IDs)
    • Equipment Layouts
    • Utility Load Calculations
    • Material & Personnel Flow Designs
  • Ensure optimal facility design for GMP compliance, operational efficiency, and scalability.
  • Process equipment URS preparation, technical bid analysis, vendor development, procurement assistant for the Upstream, Downstream equipment’s and ancillary area equipment’s.
  • Prepare and manage CAPEX budgets, monitor project expenditures, and cash flow, evaluate technical and commercial proposals, manage contractors, consultants, and OEMs, and drive value engineering and cost optimization initiatives to ensure effective project delivery within budget.
  • Lead FAT, SAT, commissioning, startup, and qualification activities, ensuring seamless execution of IQ, OQ, PQ, Process Validation readiness, and compliance with Validation Master Plans in coordination with QA and Validation teams.
  • Lead HAZOP, HIRA, FMEA, QRM, and Design Risk Assessments.

Qualifications

Education

  • B.E./B.Tech in Chemical, Biotechnology, Biochemical or Pharmaceutical Engineering

Experience

  • Team Lead / Manager: 8–15 Years

Additional Information

About the Department
Biologics

Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date.

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/#!/ 

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