Areas of Expertise Desired:
Astellas is the bright spot in the pharmaceutical industry ' not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!The Process Engineer is responsible for process development and optimization, testing, scale-up and CTM manufacturing of pharmaceutical products at APT. Additionally, this position is responsible for technology transfer or products into APT, scale up from pilot to commercial scale, and transfer of products from APT to other Astellas or contract manufacturing sites.Essential Job Responsibilities: Conducts process development and optimization in the development laboratory, pilot facility, and/or commercial facility of solid dosage oral forms. Conducts technology transfer in and out of the site. Conducts physicochemical characterization of drugs, excipients, and in-process materials. Plan, organize, design, and execute process optimization and scale-up studies; establish manufacturing processes at pilot and commercial scale. Perform statistical analysis of data and interpret results. Identify, evaluate, and implement scientific approaches and methodologies in the development of manufacturing processes for solid oral dose products. Plan, execute, and report scale-up and technology transfers from other Astellas sites to APT. Plan, execute, and report scale-up and technology transfers from development/pilot facility to commercial facility. Plan, execute, and report on the manufacturing of clinical supplies and primary stability batches for timely NDA filings. Provide technical/production support to the pilot plant and production. Prepare protocols, reports, and documentation for cGMP manufacturing in support of regulatory submissions. Investigate out-of-specification occurrences and make recommendations for corrective action. Provide timely input to supervisors, project managers, and pharmaceutical development personnel as to project status, process development, and technology transfer activities and requirements. Develop technical guidance and coordination with other engineering groups and other manufacturing sites with product transfers in order to meet established timelines. Evaluate, specify, and recommend new process equipment, data collection, and process automation for APT. Function under minimal supervision with some independent scheduling and coordination of activities. Ensure timely and accurate completion of technical tasks required for meeting internal and external project development and pilot manufacturing timeline. Strictly folSlow all applicable safety and standards guidelines, such as SOPs, cGMPs, and MSDS.
Minimum 2 years in pharmaceutical solid dosage development and technology transfer with MS or equivalent in industrial pharmacy, engineering, or scientific discipline; or 4 years in pharmaceutical solid dosage development and technology transfer with BA/BS in industrial pharmacy, engineering, or scientific discipline.
|Astellas Pharma US, Inc.|
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