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Scientist - Formulation R&D Allegan United States,  


Posted on : 19 May 2017

Project Description

Tracking Code 2015975 Job Description Perrigo is looking to expand its Formulation R&D team by adding a Scientist at their US Headquarters in Allegan, MI.  The Scientist will support development and commercialization of new or reformulated products by designing and documenting formulations which meet the company’s First-to-File and First-to-Market strategy. Major duties and responsibilities to include: Provides support to (or may lead) product/process development and commercialization activities for new immediate release and modified release solid oral dosage, liquid oral dosage forms and semisolid topical dosage forms to facilitate “First-to-File” and “First-to-Market” corporate goals.   Lead the manufacture of Pivotal/Registration lots for new products in the Product/Process Development Pilot Plant and Manufacturing facilities. Perform effective problem solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects. Generate accurate, reliable data by following established procedures and practices. Record, tabulate, summarize, interpret, report and publish study results. Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale-up and process validation batches. Analyze and defend scientific results.   With guidance, interpret in-vitro and in-vivo data to derive clear conclusions and recommend direction for future work. With guidance, prepare or co-author Product Development documents for inclusion into the eCTD and Quality Overall Summary (QOS). Hands-on formulation design, development and optimization with guidance as appropriate. Design and perform quality scientific experimentation. Contribute to the development of new experimental approaches. Design stability studies. May lead and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits. Maintain scientific currency. Acts as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provides technical support to Technical Operations, Manufacturing, Quality and to third party contractors. Ensure compliance with current Drug Enforcement Administration (DEA), current Good Manufacturing Practices (cGMP), Perrigo policies and Quality Systems, and all applicable regulatory agencies. Required Experience Knowledge of the principals and practices of pharmaceutical sciences combined with professional experience in developing and testing formulation processes in more than one dosage form or product category. Sound problem solving skills and good scientific judgment are required. Good communication skills and the ability to work on interdisciplinary teams are required. Familiarity with project management methodology is necessary. Experience in Pellet/Particle/Bead Coating is highly preferred. These skills are normally acquired through completion of a Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with 4 to 6 years of research experience in the pharmaceutical industry, or a Master's degree combined with 2 to 4 years of relevant experience, or a Doctoral degree combined with relevant experience. An Equal Opportunity Employer - M/F/D/V Job Location Allegan, Michigan, United States Position Type Full-Time/Regular

Locations

Allegan Michigan United States

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