441 Process Development Scientist jobs in India
Process Development Scientist
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Job Summary
We are seeking a dynamic and experienced Scientist in Process Development in the pharmaceutical development process, responsible for strategy evaluations, process design, optimization, scale-up calculations, and handling exhibit batches. This role involves working on oral solid formulations and technical documentation, as well as process validations, to ensure the successful development and scale-up of pharmaceutical products.
Roles & Responsibilities
- You will be responsible to Conduct strategy evaluations to design and optimize pharmaceutical processes, ensuring efficient and cost-effective development.
- You will be responsible to Calculate batch sizes for both early development and commercial production, considering critical parameters and quality standards.
- You will be responsible to Lead process development activities for oral solid formulations, from concept to commercialization, including the design of experiments and formulation strategies.
- You will be responsible to Perform scale-up calculations and execute scale-up processes to ensure successful transition from lab-scale to production-scale.
- You will be responsible to Handle exhibit batches, coordinating activities and documentation to meet regulatory requirements and project timelines.
- You will be responsible to Prepare and maintain technical documentation, including development reports, process validation protocols, and regulatory filings.
- You will be responsible to Collaborate with cross-functional teams to drive process improvements, troubleshoot issues, and ensure product quality and consistency.
- You will be responsible to Stay updated with industry trends and regulatory guidelines, incorporating best practices and innovative technologies into the development process.
Qualifications
Educational qualification: Masters in pharma/Biotechnology/Chemical Engineering
Minimum work experience: 4 - 6 years of Experience in Process Development/Manufacturing
Skills & attributes:
Technical Skills
- Experience in process optimization, development and troubleshooting in relevant dosage forms or technologies
- Hands-on experience in end-to-end scale up
- Depth understanding of process techniques & equipment knowledge
- Knowledge on Deficiency management and product validations.
- Experience in manufacturing process improvement.
- Experience with oral solid formulations.
Behavioral Skills
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Performance oriented and good at building, leveraging relationship.
- 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
Lead Process Development Scientist
Posted today
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Responsibilities:
- Lead the development and optimization of robust, scalable, and cost-effective manufacturing processes for new drug candidates and existing products.
- Design and execute experimental studies to investigate critical process parameters (CPPs) and material attributes (CMAs).
- Utilize Quality by Design (QbD) principles to develop control strategies and ensure process understanding.
- Perform process characterization, validation, and technology transfer activities.
- Analyze experimental data, interpret results, and prepare detailed reports and presentations for regulatory filings and internal reviews.
- Troubleshoot manufacturing process deviations and implement corrective and preventive actions (CAPAs).
- Collaborate with cross-functional teams including R&D, analytical development, manufacturing operations, and quality assurance.
- Manage multiple projects simultaneously, prioritizing tasks and meeting timelines.
- Stay current with industry trends, regulatory requirements, and new technologies in pharmaceutical process development.
- Mentor junior scientists and provide technical guidance.
- Contribute to intellectual property development through patent filings.
Qualifications:
- Master's or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related field.
- Minimum of 6 years of experience in pharmaceutical process development, with a proven track record in leading projects.
- Strong understanding of GMP regulations and ICH guidelines.
- Hands-on experience with process modeling, statistical analysis, and DOE is highly desirable.
- Proficiency in laboratory techniques relevant to pharmaceutical manufacturing (e.g., crystallization, filtration, drying, milling).
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong communication and interpersonal skills, with the ability to effectively present complex technical information.
- Experience in technology transfer and scale-up activities.
- Ability to work effectively in a fast-paced, team-oriented environment.
This is an exciting opportunity for a talented scientist to contribute to the advancement of pharmaceutical manufacturing and make a tangible difference in patient lives. Join our client and be part of a company dedicated to improving global health.
Lead Process Development Scientist
Posted 3 days ago
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Responsibilities:
- Design, develop, and optimize chemical synthesis and manufacturing processes for new pharmaceutical products.
- Conduct detailed process research and development studies, including reaction kinetics, thermodynamics, and impurity profiling.
- Scale-up processes from laboratory to pilot plant and commercial manufacturing, identifying and mitigating potential risks.
- Develop robust analytical methods for in-process control and final product release testing.
- Collaborate closely with R&D, manufacturing, and quality assurance teams to ensure seamless technology transfer.
- Prepare comprehensive development reports, technical documentation, and regulatory submissions (e.g., IND, NDA).
- Troubleshoot and resolve process-related issues encountered during development and manufacturing.
- Stay updated with the latest advancements in pharmaceutical process technology and chemical engineering.
- Mentor junior scientists and contribute to a culture of continuous improvement and innovation.
- Ensure all activities are conducted in compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Evaluate and implement new technologies to enhance process efficiency and sustainability.
- Manage project timelines and resources effectively to meet R&D objectives.
- Perform risk assessments for new and existing processes.
- Ph.D. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
- Minimum of 8 years of experience in pharmaceutical process development, with a strong understanding of synthetic organic chemistry and process scale-up.
- Proven track record of successfully developing and transferring chemical processes for API manufacturing.
- Expertise in analytical techniques such as HPLC, GC, MS, NMR, and KF titration.
- Familiarity with regulatory requirements (FDA, EMA) and cGMP manufacturing environments.
- Excellent problem-solving and critical thinking skills.
- Strong project management and organizational abilities.
- Effective communication and presentation skills, with the ability to collaborate across multidisciplinary teams.
- Experience with Design of Experiments (DoE) and statistical analysis is a significant advantage.
- Ability to work effectively in a hybrid work environment, balancing on-site laboratory work with remote data analysis and reporting.
Process Development Scientist - Pharmaceuticals
Posted 5 days ago
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Principal Process Development Scientist
Posted 8 days ago
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Key Responsibilities:
- Lead the development and optimization of chemical synthesis routes for active pharmaceutical ingredients (APIs) and intermediates.
- Design and execute experiments to optimize reaction parameters, crystallization, and purification processes.
- Develop and validate scalable manufacturing processes in compliance with GMP guidelines.
- Troubleshoot and resolve complex technical issues encountered during process development and scale-up.
- Supervise and mentor a team of process development scientists and engineers.
- Collaborate with analytical teams to develop and validate in-process controls and release methods.
- Prepare detailed technical reports, development summaries, and regulatory documentation.
- Evaluate and implement new process technologies and analytical techniques.
- Ensure all activities comply with safety, environmental, and quality regulations.
Qualifications:
- Ph.D. in Organic Chemistry, Chemical Engineering, or a related field.
- 10+ years of relevant experience in pharmaceutical process development.
- Proven track record of successfully scaling up chemical processes from lab to pilot and commercial scale.
- Extensive knowledge of GMP regulations and ICH guidelines.
- Experience with process analytical technology (PAT) and Quality by Design (QbD) principles.
- Strong leadership, project management, and communication skills.
- Proficiency in data analysis and statistical software.
Principal Process Development Scientist
Posted 9 days ago
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Chemical Process Development Scientist
Posted 10 days ago
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Senior Process Development Scientist
Posted 10 days ago
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Senior Process Development Scientist
Posted 10 days ago
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Key Responsibilities:
- Design, execute, and analyze experiments to develop and optimize chemical synthesis routes and manufacturing processes.
- Scale up chemical processes from laboratory bench to pilot plant and eventually to commercial production.
- Characterize raw materials, intermediates, and final products using various analytical techniques.
- Troubleshoot process issues and identify root causes for deviations, implementing effective corrective actions.
- Develop and validate analytical methods for process monitoring and quality control.
- Conduct process hazard analyses and implement safety protocols to ensure safe operations.
- Collaborate with research scientists, engineers, and production teams to ensure seamless technology transfer and implementation.
- Prepare detailed technical reports, documentation, and presentations for internal review and regulatory submissions.
- Stay abreast of new technologies, methodologies, and regulatory requirements in chemical process development.
- Mentor junior scientists and provide technical guidance.
- Manage project timelines, resources, and budgets effectively.
- Ensure compliance with all relevant safety, environmental, and quality regulations.
- Ph.D. or Master's degree in Chemical Engineering, Organic Chemistry, or a related field.
- Minimum of 7 years of experience in process development, scale-up, and optimization within the chemical or pharmaceutical industry.
- Proven track record of successfully developing and scaling complex chemical processes.
- Extensive hands-on experience with laboratory synthesis, process chemistry, and analytical techniques (e.g., HPLC, GC, MS, NMR, IR).
- Strong understanding of reaction kinetics, thermodynamics, mass transfer, and heat transfer principles.
- Experience with process simulation software (e.g., Aspen Plus, HYSYS) is a plus.
- Familiarity with Good Manufacturing Practices (GMP) and relevant regulatory guidelines.
- Excellent problem-solving, analytical, and critical-thinking skills.
- Strong written and verbal communication skills, with the ability to present complex technical data clearly.
- Ability to work independently, manage multiple projects, and meet deadlines in a remote setting.
- A proactive approach to safety and a commitment to environmental stewardship.
Process Development Scientist (Remote)
Posted 12 days ago
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Job Description
Key Responsibilities:
- Design and execute experiments to develop and optimize chemical synthesis routes and purification methods.
- Investigate and resolve issues related to process efficiency, yield, purity, and safety.
- Scale up chemical processes from laboratory to pilot plant and ultimately to commercial production.
- Develop and validate analytical methods for process monitoring and product characterization.
- Utilize process modeling and simulation tools to predict process behavior and optimize operating parameters.
- Conduct thorough hazard assessments and implement appropriate safety protocols for chemical processes.
- Collaborate with R&D chemists, engineers, and manufacturing personnel to ensure seamless technology transfer.
- Prepare detailed technical reports, documentation, and presentations on process development activities.
- Stay current with advancements in chemical engineering, process intensification, and green chemistry principles.
- Evaluate and recommend new technologies and equipment for process improvement.
- Contribute to intellectual property generation through patent filings and publications.
- Ensure compliance with all regulatory requirements and industry best practices.