Senior Process Development Engineer

3 weeks ago

Canada Dr. Reddy's Laboratories Ltd Full time
Company Overview

Dr. Reddy's Laboratories Ltd. is a prominent global pharmaceutical organization with a presence in numerous countries. Our dedicated workforce of over 24,000 individuals is united by a singular mission: to enhance access to affordable and innovative medications because Good Health Can't Wait.

Founded in 1984 with a small team and a visionary outlook, we have expanded our operations to include research and development centers, manufacturing sites, and commercial activities in 66 nations.

For nearly four decades, we have championed access, affordability, and innovation, grounded in profound scientific knowledge, progressive workforce practices, and strong corporate governance. As the pharmaceutical landscape evolves, we recognize the opportunity to further solidify our core and shape the future.

Dr. Reddy's is committed to fostering a workplace free from discrimination and is an equal opportunity employer. We value every talent and celebrate diversity and merit within our organization.


Position Summary

We are in search of a skilled and experienced professional in Process Engineering focused on Active Pharmaceutical Ingredient (API) development, with a proven track record in scaling technologies to meet production requirements. The ideal candidate will possess a strong foundation in Process and Chemical Engineering, with the ability to troubleshoot intricate projects, facilitate technology transfers, and enhance operational efficiency. Experience in unit operations such as crystallization, filtration, drying, and size reduction is essential, along with a commitment to quality and adherence to regulatory standards.


Key Responsibilities
  • Lead the development and scale-up of processes for new products, including Technology Transfer and Process Validation at the plant level.
  • Collaborate with the Chemistry team to provide essential insights during Design of Experiments (DoE) studies and subsequent process enhancements.
  • Establish a comprehensive understanding of processes and ensure scalability through fundamental studies in reaction kinetics, crystallization, process safety, and Process Analytical Technology (PAT).
  • Ensure accurate mapping of facilities, equipment, and technologies at in-house and contract manufacturing plants.
  • Draft detailed processes for scale-up, including Kilo lab operations, Critical Process Parameters (CPP), and validation batches in coordination with cross-functional teams.
  • Oversee Technology Transfer and scale-up of Active Pharmaceutical Ingredients (API) and engineering optimization studies with minimal supervision.
  • Support Drug Master Filing (DMF) efforts, address regulatory inquiries related to process engineering, and maintain awareness of process validation, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) to facilitate seamless regulatory submissions.
  • Stay informed about the Intellectual Property (IP) landscape and relevant literature, engage in industry forums, and share knowledge within Process Engineering teams, applying existing insights and technologies during development.
  • Proactively plan and ensure timely completion of Process Engineering tasks in alignment with project objectives.
  • Work collaboratively within cross-functional teams to drive Process Engineering initiatives.

Qualifications

Educational Background: B.Tech in Chemical Engineering

Experience: Minimum of 7 years in process development and scale-up of at least 6-8 products.


Technical Skills
  • Experience in scaling up processes for Active Pharmaceutical Ingredients.
  • Strong knowledge of core chemical engineering principles such as heat and mass transfer, reaction engineering, fluid dynamics, and separation technologies for process optimization and scale-up.
  • Familiarity with Operational Excellence and scale-up processes.
  • Understanding of product development, chemistry, analytical processes, regulatory affairs, and intellectual property.
  • Experience in Technology Transfer processes.
  • Proficient in Current Good Manufacturing Practice (CGMP) standards and quality systems within the pharmaceutical industry.
  • Knowledge of engineering optimization tools such as Design of Experiments (DoE) and Dynochem.

Behavioral Skills
  • Exceptional communication and interpersonal abilities.
  • Strong analytical and problem-solving skills.
  • Ability to collaborate effectively with team members and cross-functional groups.

Additional Information

About the Department

Integrated Product Development Organization

We combine our extensive scientific expertise and advanced technology to create innovative, accessible, and affordable therapies for patients globally. Our commitment is to accelerate access to healthcare solutions for patients worldwide.


Benefits Offered

At Dr. Reddy's, we are dedicated to fostering your career growth and professional development through tailored learning programs. Our benefits are competitive and include relocation support, family benefits (maternity and paternity leave), opportunities for learning and development, and comprehensive medical coverage for you and your family, along with life insurance.


Our Work Culture

Ask any employee at Dr. Reddy's why they come to work every day, and they will tell you it is because Good Health Can't Wait. This principle guides all our actions and fosters a culture of empathy and dynamism. Our people are at the heart of our journey over the years.

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