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Job #03452

About our client Our client is global pharmaceutical company based in Utah that focuses on the development and commercialization of allergy vaccinations (immunotherapy). The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of it's employees. Position Location Product Development Manager Spokane, WA Salary Highly competitive package, commensurate with experience Responsibilities 1) Accurately record data such as observations, measurements and reports results and maintains required documentation 2) Authors qualification, validation, stability and overall development protocols and reports 3) Design, plan, complete, analyze and report experiments 4) Test process equipment to determine critical process parameters relevant for design of equipment and scale up 5) Plan and report new process validation/qualification/verification studies 6) Review PFDs, P&IDs 7) Give input to relevant CMC sections to PMPs, IMPDs, INDs and CTD files 8) Approve experimental results 9) Participate in projects across the organization 10) Work with the engineering department for equipment determination, qualification and plant designs Requirements 1) Bachelor’s degree (Master’s preferred) in biological science biochemistry, chemistry or related field and minimum relevant experience of 5 years with a masters and minimum 8-10 with a bachelors or equivalent combination of education and relevant experience 2) Ability to work with Quality Systems and regulatory requirements such as: CFPs, GMP, FDA, OSHA, European Authority 3) Ability to create PFDs and review P&Ids 4) Ability to act as source material responsible person within a global CMC development project 5) Must be able to travel internationally 6) Able to work around hazardous chemicals, allergenic antigens and medically qualified to use a respirator without restrictions