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IVIVC Modeling and Dissolution Scientific Leader

Date: Apr 8, 2021

Location: North York, ON, CA, M9L 1T9

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

 

Job Summary

 

The Scientific Leader acts as a part of a multifunctional team focused primarily on development of new drug products. Responsible for coordination of activities related to dissolution research for new products development. Performs IVIVC modelling  Collaborates closely with Formulation Development and Analytical Development Scientific Leaders to identify and evaluate strategies for formulation design, facilitate product development and ensure bioequivalence with the reference product, supports post-approval changes and product life-cycle management. Provides Statistical Support for Global Apotex Solid Dose and Liquids- Formulation Development and Technical Operations groups.

Job Responsibilities

 

  • Assessment of relevance of in vitro dissolution/release characteristics on in vivo product performance and selection of bioindicative dissolution conditions for product development
  • IVIVC modeling in support of development of dissolution method& specification
  • Risk-assessment for bioequivalence studies based on IVIVC 
  • IVIVC modelling in support of formulation& process changes
  • Evaluation of the results of bio-studies and advising on formulation strategies 
  • Evaluation and characterization of Reference Product based on experimental and theoretical data to identify critical attributes and define target product profile 
  • Preparation of waivers for bioequivalence studies for regulatory submissions 
  • Preparation of dissolution test method development reports for regulatory submissions 
  • Preparation of scientific reports/justifications in response to deficiency letters and/or justification of post-approval changes
  • Knowledge of statistical methodologies is an asset

Job Requirements

 

  • MSc with 7 years or PhD with 5 years of relevant experience 
  • Understanding of dissolution theory and experience in dissolution method development
  • Expert knowledge of pharmacokinetics and IVIVC concept
  • Knowledge and experience with statistical software (i.e. SAS, JMP) would be an asset
  • Knowledge of ICH, FDA, TPD and other regulator guidance documents  in-depth understanding of all pertinent SOPs, GMP, GLP and GDP
  • Six Sigma Belt certification, CSA/ASA membership is a preference
  • Multi-tasking and project management skills
  • Well-developed interpersonal and team skills
  • Strong verbal and written English communication skills
  • Computer literacy: word processing, chemistry drawing, literature search and data generation software

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
 
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.