Team Member Process Development

As a Process Development professional, you will play a crucial role in optimizing processes, executing trials, and supporting batch scale-up in a dynamic pharmaceutical environment. Your responsibilities will include: - Providing critical inputs in process design and execution of experiments. - Collecting and interpreting data for smooth process scale-up and effective process control. - Collaborating with cross-functional teams and applying Quality by Design (QbD) principles. - Finalizing batch sizes and equipment trains for successful scale-up and technology transfer. - Demonstrating successful process scale-up for confirmatory & exhibit batches. - Preparing necessary documents for confirmatory/scale-up batches at the plant. - Performing Scale Up correlations for all unit operations from lab scale to plant scale. - Providing control strategy for Exhibit Batches based on Confirmation Batch (CB) results. - Preparing Process optimization report & filing documents. - Analyzing data and supporting in addressing process-related deficiencies for regulatory compliance. - Developing process capabilities within the team and providing training to new members. Qualifications required for this role include: - Educational qualification: Masters/Bachelors/Ph.D in pharma. - Minimum work experience: 3-5 years in Process development. Desired Skills & Attributes: Technical Skills: - Experience in product development, scale-up, and technology transfer in relevant dosage forms or technologies. - Understanding of pharmaceutical process selection and ability to prepare technical protocols and reports. - Proficiency in process engineering, Quality by Design (QbD) principles, and risk assessment approaches. - Knowledge of ICH guidelines related to Product development or Process Development. - Experience in Formulation Development and analytical research. Behavioral Skills: - Excellent communication and interpersonal skills. - Strong analytical and problem-solving abilities. - Performance-oriented with a focus on building relationships. - Ability to collaborate effectively with own team and cross-functional teams. - Committed to continuous learning and coaching the team. As a Process Development professional, you will play a crucial role in optimizing processes, executing trials, and supporting batch scale-up in a dynamic pharmaceutical environment. Your responsibilities will include: - Providing critical inputs in process design and execution of experiments. - Collecting and interpreting data for smooth process scale-up and effective process control. - Collaborating with cross-functional teams and applying Quality by Design (QbD) principles. - Finalizing batch sizes and equipment trains for successful scale-up and technology transfer. - Demonstrating successful process scale-up for confirmatory & exhibit batches. - Preparing necessary documents for confirmatory/scale-up batches at the plant. - Performing Scale Up correlations for all unit operations from lab scale to plant scale. - Providing control strategy for Exhibit Batches based on Confirmation Batch (CB) results. - Preparing Process optimization report & filing documents. - Analyzing data and supporting in addressing process-related deficiencies for regulatory compliance. - Developing process capabilities within the team and providing training to new members. Qualifications required for this role include: - Educational qualification: Masters/Bachelors/Ph.D in pharma. - Minimum work experience: 3-5 years in Process development. Desired Skills & Attributes: Technical Skills: - Experience in product development, scale-up, and technology transfer in relevant dosage forms or technologies. - Understanding of pharmaceutical process selection and ability to prepare technical protocols and reports. - Proficiency in process engineering, Quality by Design (QbD) principles, and risk assessment approaches. - Knowledge of ICH guidelines related to Product development or Process Development. - Experience in Formulation Development and analytical research. Behavioral Skills: - Excellent communication and interpersonal skills. - Strong analytical and problem-solving abilities. - Performance-oriented with a focus on building relationships. - Ability to collaborate effectively with own team and cross-functional teams. - Committed to continuous learning and coaching the team.