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Senior Scientist / Principal Scientist - Formulation R&D Allegan United States,  


Posted on : 03 June 2017

Project Description

Tracking Code 2016043 Job Description   Lead formulation/process development and commercialization activities (as either an individual contributor or technical leader of junior level scientists) for variety of dosage forms (solid, liquid, semisolid, ophthalmic) using QbD principles. Interfacing with Analytical Research & Development scientists, Technical Operations, RA, QA 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. May supervise and mentor team of junior level scientists and technicians in the design and execution of product development activities. Design and perform quality scientific experimentation to develop robust processes in support of Formulation / Process Development activities. Contribute to the development of new experimental approaches. Analyze and defend scientific results from experiments. Generate accurate, reliable data by following established procedures and practices to support product development. Record, tabulate, summarize, interpret, report and publish results. Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale-up and process validation batches. 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. Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects. Communicates effectively to project manager and the wider development team and presents data at team meetings and departmental technical meetings. Leads and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits. 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. Expert with QbD principles. Expert in writing parts of ANDA submission relevant to the formulation / process development. Sound problem solving skills and good scientific judgment are required. Good communication skills and the ability to work on interdisciplinary teams are required. Hands on small scale equipment and good understanding of large scale conventional pharmaceutical equipment is required. Familiarity with project management methodology is necessary. These skills are acquired through completion of a Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with 6 to 10 years of research experience in the pharmaceutical industry, or a Master’s degree combined with 4 to 6 years of relevant research experience, or a doctoral degree combined with up to 2 - 4 year of relevant research 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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