Scientific Leader- Biowaivers & Biocorrelation, Biopharmaceutics

Job Summary

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 a team (FD scientists) 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.

Job Responsibilities

Supports product development activities at all stages, including:

• Literature evaluation of physicochemical, biopharmaceutical proprieties and pharmacokinetics data of drug substances and drug products.
• Determiantion of biopharmaceutical classification of the drug substance based on the literature information and experimental data.
• Evaluation and characterization of Reference Product based on experimental and theoretical data to identify critical attrubutes and define target product profile
• Assessment of relevance of in vitro dissolution/release characteristics on in vivo product performance and selection of bioindicative dissolution conditions for product development.
• Selection of dissolution conditions and dissolution specifications during product development
• Determination and risk assessment of potential candidates for BCS-based biowaiver and foreign reference filling
• IVIVC modelling
• Risk-assessment for bioequivalence studies based on IVIVC;
• Evaluation of the results of bio-studies and advising on formulation strategies;
• Preparation of protocols for biopharmaceutics tests such as pH solubility and dissolution tests, gastrointestinal stability tests, apple sauce stability test, alcohol dose dumping test and NG tube tests.  
• Preparation of waivers for bioequivalence studies for regulatory submissions (BCS-based; additional strengths; foreign reference; manufacturing changes).
• Preparation of dissolution test method development reports for regulatory submissions
• Preparation of test-requests for dissolution testing for biowaivers and deficiency responses
• Coordination of necessary dissolution work for NPD submissions and deficency responses.
• Assessment of impact of scale-up, optimization studies, site-transfers on bioavailability/bioequivalence;
• Preparation of biowaivers for post-approval changes (i.e. additional strengths and/or changes in the process/formulation);
• Providing technical support to other departments for the issues related to dissolution method and drug product release.
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
• Works as a member of a team to achieve all outcomes;
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion and
• All other relevant duties as assigned.

Job Requirements

• Education
  • Recognized post secondary education in analytical chemistry, pharmaceutical sciences or related field.
• Knowledge, Skills and Abilities
  • Knowledge of all the elements of new product development process.
  • In-depth understanding of dissolution theory and knowledge of dissolution method development and validation.
  • Knowledge of principles of pharmacokinetics and IVIVC concept.
  • Knowledge of ICH, FDA, TPD and other regulatory guidance documents; in-depth understanding of all pertinent SOPs, GMP, GLP and GDP.
  • Knowledge of wet chemistry, analytical bench techniques
  • Understanding of chromatographic method development and method validation.
  • Excellent written and verbal English communication skills.
  • Computer literacy: word , excel, powerpoint, chemistry drawing, JMP, literature search and data generation software

• Experience
  • MPharm with 8-10 years or PhD with 5-7 years experience in biopharmaceutics/ IVIVC modelling roles.