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Scientist - Formulation R&D - United States  

Perrigo (company)


Posted on : 19 May 2017

Project Description

Job Description 
  • Our company  is looking to expand its Formulation R&D team by adding a Scientist at their US Headquarters.
  • 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), company 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.