Principal Scientist (Ref# PS1113GN) - Teva Pharmaceuticals USA, Inc.
Company: Teva Pharmaceuticals USA, Inc.
Posted on: December 5, 2019
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.
Keywords: Teva Pharmaceuticals USA, Inc., Miami , Principal Scientist (Ref# PS1113GN) - Teva Pharmaceuticals USA, Inc., Healthcare , Weston, Florida
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