Scientist- Process Engineering focused on the areas below.
- Support activities related to the enhancement of existing products/processes and implementation of new product launches including execution of process validation. Conduct evaluations and experimental studies designed to develop and optimize existing product formulations and manufacturing processes.
- Assist in the coordinated activities with pharmaceutical development (PD) for new product scale-up and manufacturing ANDA submission batches. Assist in the generation of user requirements, functional specifications, and design specifications as required for equipment related to the supported project team.
- Contribute to oral dosage formulation process development, process scale up and technology transfer to commercialization throughout the product life cycle.
- Support scientific studies to investigate exception occurrences, atypical observations, change control proposals and customer complaints. Understand and support the activities associated with the operation of pilot scale & commercial pharmaceutical manufacturing equipment. Tabulate and perform statistical analysis of all study data, present conclusions with clear, logical, scientific explanations and justifications via technical report.
- Support change requests for resolution of production issues and deviations to ensure supply and business continuity. Support continuous process monitoring. Participate in troubleshooting, problem solving, failure analysis, root cause, and corrective/preventative actions.
- Evaluate formulation and process to determine their effects in relation to final product specification, including evaluating equipment set points and process parameters for their impacts on final product characteristics.
- Participation in formulation process evaluation early in the process development stage and participate in project risk assessments with Pharmaceutical Development and Operations. Support the design, plan and execution of scale up and robustness evaluation of formulation processes, collaborating with Production, Engineering, and Quality to optimize productivity, yield, product quality, and supply reliability.
- Bachelor’s degree in a scientific or technical field (chemistry, engineering, chemical engineering, life science) and a minimum of 4+ years of experience working in the pharmaceutical industry OR Master’s degree in a scientific or technical field and a minimum of 2+ years of experience working in the pharmaceutical industry.
- Experience with oral solid dosage, formulation, and tablet and capsulation experience.
- Ability to investigate deviations to determine product impact.
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