Dr. Reddy’s Laboratories Pharma Process Development Scientist, Apply Now
Process Development Scientist
Greater Kolkata Area
Job Summary
We are seeking a dynamic and experienced person in Process Development to plan and execute process optimization trials, execute scale-up/confirmatory batches, and support pilot and exhibit batches by applying various engineering concepts during optimization and scale-up.
Roles & Responsibilities
You will be responsible for providing critical inputs in process design, executing experiments, and collecting and interpreting data to facilitate smooth process scale-up and ensure effective process control. This role involves collaborating with cross-functional teams, utilizing Quality by Design (QbD) principles, and finalizing batch sizes and equipment trains for successful scale-up and technology transfer.
You will be responsible for demonstrating successful process scale-up to ensure smooth execution of confirmatory & exhibit batches on time.
You will be responsible for preparing documents required for confirmatory/scale-up batches at the plant. Perform scale-up correlations for all unit operations from lab scale to plant scale and provide a control strategy for exhibit batches based on confirmation batch (CB) results.
You will be responsible for preparing process optimization reports & filing documents.
You will be responsible for analyzing data and providing support in answering process-related deficiencies, ensuring on-time responses
to regulatory agencies.You will be responsible for developing process capabilities within the team, training new joiners/freshers, and supporting young talent in the initial stages.
Qualifications
Educational Qualification: Masters/Bachelors/Ph.D. in Pharma
Minimum Work Experience: 3-5 years of experience in Process Development
Skills & Attributes
Technical Skills
- Experience in the development/scale-up/technology transfer of products in relevant dosage forms or technologies.
- Understanding of pharmaceutical process selection.
- Ability to prepare technical protocols and reports.
- Experience in process engineering, Quality by Design (QbD) principles, and risk assessment approaches.
- Knowledge of International Council for Harmonisation (ICH) guidelines related to product development or process development.
- Experience in formulation development and understanding of execution methodology (based on Critical Material Attributes and Critical Quality Attributes of products).
- Experience in analytical research and knowledge of data interpretation.
Behavioral Skills
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Performance-oriented and good at building and leveraging relationships.
- Ability to work collaboratively with own team and cross-functional teams.
- Committed to learning & coaching the team.
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