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 various countries. Our dedicated workforce of over 24,000 individuals is united by a common mission: to enhance access to affordable and innovative healthcare solutions because Good Health Can't Wait.

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

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

Our vision, encapsulated in 'The Next and the New,' reflects our commitment to being a purpose-driven, future-ready, and sustainable partner. By 2030, we aim to positively impact over 1.5 billion patients globally by expanding our core operations and integrating sustainability into our strategy.

Dr. Reddy's fosters an inclusive work environment, committed to equal opportunity employment. We embrace and support a diverse workforce, regardless of race, color, religion, nationality, gender, age, disability, genetics, sexual orientation, gender identity, citizenship, or any other legally protected characteristic.

Position Overview
We are in search of a skilled and experienced Process Development Engineer specializing in Active Pharmaceutical Ingredient (API) development. The ideal candidate will possess a proven track record in scaling technologies to meet production requirements. You should be proficient in Process and Chemical Engineering, with a strong aptitude for troubleshooting complex projects, facilitating technology transfers, and optimizing operational efficiencies.

Key Responsibilities

  • Lead the development and scale-up of processes for new products, including technology transfer and process validation at plant scale.
  • Collaborate with the Chemistry team to provide essential insights during Design of Experiments (DoE) studies and further process optimization.
  • Develop a comprehensive understanding of processes and ensure scale-up feasibility through fundamental studies in reaction kinetics, crystallization, process safety, and process analytical technology (PAT).
  • Conduct facility, equipment, and technology mapping at in-house and contract manufacturing plants.
  • Draft processes for scale-up, including Kilo lab, Critical Process Parameters (CPP), and validation batches in coordination with cross-functional teams.
  • Support technology transfer and scale-up of APIs, along with engineering optimization studies with minimal supervision.
  • Assist in Drug Master Filing (DMF) and address regulatory inquiries related to process engineering, demonstrating knowledge of process validation, GMP, and GLP to facilitate regulatory submissions.
  • Stay informed about the Intellectual Property (IP) landscape and relevant literature, engage in industry forums, and share knowledge within the Process Engineering teams.
  • Proactively plan and execute Process Engineering tasks in alignment with project objectives.
  • Work collaboratively within cross-functional teams to advance 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 Active Pharmaceutical Ingredients.
  • Strong knowledge of core chemical engineering principles, including heat and mass transfer, reaction engineering, fluid dynamics, and separation technologies for process optimization.
  • Proven experience in operational excellence and scaling processes.
  • Familiarity with product development, basic chemistry, analytical processes, regulatory affairs, and intellectual property.
  • Experience in technology transfer processes.
  • Knowledge of Current Good Manufacturing Practice (CGMP) and quality systems in the pharmaceutical sector.
  • Proficiency in 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 both internal teams and cross-functional partners.

About the Department
Integrated Product Development Organization
We combine our extensive scientific expertise with cutting-edge technology to create innovative, accessible, and affordable therapies for patients worldwide. Our commitment is to accelerate access to healthcare solutions for patients globally.

Benefits Offered
At Dr. Reddy's, we actively support your career growth and professional development through tailored learning programs. The benefits provided are competitive and align with industry standards.

Our Work Culture
Every employee at Dr. Reddy's is driven by the belief that Good Health Can't Wait, which serves as our guiding principle in all our endeavors.



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