Teva Pharmaceuticals USA, Inc.

Associate Director, Analytical R&D (Generic Pharmaceuticals)

US-FL-Weston
Requisition #
17-19801
# Positions
1
Experience (Years)
8
Category
Research & Development - Analytical

Overview

Teva Pharmaceuticals, the World's Generic Pharmaceutical Leader is currently seeking an Associate Director, Analytical R&D to join our Generics R&D team in Weston, FL.  Reporting to the Director Analytical, R&D, the Associate Director will lead a team of analytical scientists to solve complex technical issues related to drug substances and drug products.

 

Responsibilities

  • Support the analytical teams in the isolation and spectroscopic characterization of organic impurities, including unknown degradation products, in drug substances and drug products by means of preparatory chromatography, liquid chromatography-mass spectrometry (LC-MS), nuclear magnetic resonance (1H-NMR and 13C-NMR), infrared spectroscopy (FT-IR) and elemental analysis.
  • Identification of polymorphic forms in drug substances and drug products using powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Raman spectroscopy and hot stage microscopy.
  • Evaluate transformation of polymorphic forms through polymorphs screening at different stages (manufacturing, stability) in drug substances and drug products using powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), Raman spectroscopy and hot stage microscopy.
  • Develop and validate analytical procedures to identify and quantify polymorphs in mixtures present in drug substances and drug products.
  • Identification of extraneous peaks exceeding thresholds obtained during the residual solvents analysis of drug substances and drug products using gas chromatography coupled to mass spectrometry (GC-MS)
  • Optimization of analytical procedures to quantify organic impurities in drug substances and drug product.
  • Characterization of particles (distribution by sizes, shapes) in drug substances and drug products using laser diffraction techniques (e.g. Malvern 3000, Morphologi G3) and microscopy.
  • Conduct reverse engineering studies (deformulation) of brand drug products.
  • Support the analytical department in responses to deficiencies included in regulatory letters (FDA Information request letters, FDA Complete response letters, among others).
  • Support the analytical department during general GMP and pre-approval inspections conducted by different regulatory bodies.
  • Lead a team of analytical scientists.   Provides technical guidance, coaching, and performance feedback. Carries out management responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
  • Directs, reviews and validates analytical methods and procedures to assure that the finished product meets safety requirements during all phases of New Product Development.
  • Evaluates products using accurate, specific and precise analytical measures to assure the validity of the data.
  • Assures accurate and timely testing and reporting of all results; issues technical reports which include all certification and validation data.
  • Manages the preparation of CMC section of regulatory submissions, assures accuracy and validity of data submitted by assuring appropriate documentation and storage of original data, and that all information has been certified as to accuracy and validity.

 

Qualifications

 

Ph. D. degree in Organic Chemistry from an accredited college or university, and eight (8) years pharmaceutical organic chemistry experience, including two (2) years in a supervisory or management capacity, or an equivalent combination of education and experience.

 

Knowledge of:

  • Strong and deep experience in synthetic organic chemistry.
  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
  • Pharmaceutical principles, practices and their application.
  • Pharmaceutical and instrumental analyses and testing principles, techniques, applications and equipment.
  • Project management principles and techniques.

 

Skilled in:

  • Highly skilled in analytical techniques such as HPLC, LC-MS, GC-MS, IR, NMR, DSC, TGA, PXRD, Hot stage microscopy, among others, to analyze complex mixtures in drug substances, formulation and manufacturing.
  • Evaluation of synthesis routes for drug substances, identifying regulatory starting materials, intermediates, by-products and potential degradation products.
  • Skilled in aspects of drug discovery and development, resulting in sound understanding of structure-activity relationship development, QSAR studies, pharmacokinetics, formulation and pre-clinical toxicology.
  • Prediction of organic impurities genotoxicity alerts based on chemical structure and literature information.
  • Planning, implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources and highest quality of product satisfaction.
  • Analyzing problems, projecting consequences of proposed actions, and implementing recommendations that support department goals and objectives.
  • Researching, analyzing and evaluating new product development materials, methods, procedures and techniques.
  • Strong written and oral communication skills.
  • English usage, spelling, grammar and punctuation.
  • Writing and evaluation of reports and other key documents.
  • Managing and organizing multiple projects and assignments.
  • Establishing and maintaining effective working relationships with others.

 

#Linkedin

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.