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Principal Scientist (Ref# PS1113GN) - Teva Pharmaceuticals USA, Inc.

Company: Teva Pharmaceuticals USA, Inc.
Location: Weston
Posted on: December 5, 2019

Job Description:

Teva Pharmaceuticals USA, Inc. has an opening for the position of Principal Scientist (Ref# PS1113GN).
Work Location: 2945 W. Corporate Lakes Blvd. Weston, FL 33331.
Job Duties: Under limited direction and supervision, participate as a project team member and/or leader in Formulation Research and Development (Product Development). Perform highly technical and specialized professional Scientist duties in formulation development of drug products. Design and conduct pre-formulation, formulation development, process development, process optimization, scale-up, and clinical manufacturing on assigned projects for new drug products. Develop immediate release and modified release solid oral dosage forms. Develop extended release, delayed release, controlled release, multiparticulate and abuse-deterrent formulations. Plan and execute strategies for formulation development and solve complex problems. Troubleshoot problems encountered during formulation development and process development to develop robust, scalable, stable drug product. Conduct literature search for the projects including publications, patents, etc. Review and authorize reports/documents such as product development reports, quality overall summary, master formulas, and other key reports/documents. Coordinate with other Teva development and manufacturing sites. Provide technical assessments on alternative drug delivery technologies. Involved in process validation when needed. Involved in identifying analytical testing conditions along with analytical development. Organize and procure materials and equipment for the execution of batches. Conduct briefings and technical meetings for top management representatives. Represent Formulation Development and act as subject-matter expert with government agencies, such as the Food and Drug Administration (FDA) during the Pre-Approval Inspection (PAI) process or in responding to deficiencies to submitted ANDAs (abbreviated new drug applications). Provide technical and scientific guidance to junior scientists for drug product development. Apply quality by design principles in product and process development. Carry out lead responsibilities in accordance with the organization's policies, procedures, and state, federal, and local laws. Develop project goals and execute assigned projects in compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs). Efficiently handle pharmaceutical operations such as fluid bed coating, compression, roller compaction, high shear granulation, particle and tablet coating, encapsulation, and packaging. Critically analyze, compile, and present data. Perform research on assigned projects in support of the company's goals. Identify, analyze, and suggest corrective actions to optimize R&D processes, technology, and regulatory compliance. Provides intra- and inter-departmental technical assistance and training. Maintain appropriate documentation of records, report sheets, and laboratory notebooks as required by SOPs and FDA. Develop bioequivalent formulation by applying knowledge of pharmacokinetics and biopharmaceutics. Perform administrative functions to assure compliance with government regulations, GMPs, and company policies.
Requirements: This position requires a Master's degree or foreign academic equivalent in Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, or a related field. Plus 7 years of experience in the job offered or 7 years in a related occupation including Formulation Research Scientist, Formulation Chemist, Formulation Development Manager, or related pharmaceutical industry experience. Position requires 5 years of experience with formulation development of solid oral dosage forms, process development, ANDAs, and GMP. 40hrs/week.
Application Instructions: To apply, please email your resume to Jill Aichroth, Team Lead - Talent Acquisition, ensuring to indicate the position reference code (Ref# PS1113GN) for which you are applying. Email to: Jill.Aichroth@tevapharm.com.
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Keywords: Teva Pharmaceuticals USA, Inc., Miami , Principal Scientist (Ref# PS1113GN) - Teva Pharmaceuticals USA, Inc., Healthcare , Weston, Florida

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