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    Scientific Leader- Biowaivers & Biocorrelation, Biopharmaceutics

    Apotex
    5-10 years
    Not Disclosed
    10 May 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Company: Apotex Inc.

    About Apotex Inc.: Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar, and specialty products. For more information, visit Apotex.

    Position: Biopharmaceutics Scientist

    Job Summary: The Biopharmaceutics Scientist is part of a multifunctional team focused on the development of new drug products. This role coordinates activities related to dissolution research for new product development, performs IVIVC modeling, collaborates with formulation design scientists, and supports post-approval changes and product lifecycle management.

    Responsibilities:

    • Product Development Support:
      • Evaluate literature on physicochemical, biopharmaceutical properties, and pharmacokinetics data of drug substances and products.
      • Determine biopharmaceutical classification of drug substances based on literature and experimental data.
      • Characterize Reference Products using experimental and theoretical data to identify critical attributes and define the target product profile.
      • Assess the relevance of in vitro dissolution/release characteristics on in vivo product performance.
      • Select bio-indicative dissolution conditions and specifications during product development.
      • Determine and assess potential candidates for BCS-based biowaivers and foreign reference filing.
      • Perform IVIVC modeling and risk assessment for bioequivalence studies.
      • Evaluate bio-study results and advise on formulation strategies.
      • Prepare protocols for biopharmaceutics tests such as pH solubility, gastrointestinal stability, apple sauce stability, alcohol dose dumping, and NG tube tests.
      • Prepare waivers for bioequivalence studies for regulatory submissions.
      • Develop dissolution test methods and prepare related reports for regulatory submissions.
      • Coordinate dissolution work for NPD submissions and deficiency responses.
      • Assess the impact of scale-up, optimization studies, and site-transfers on bioavailability/bioequivalence.
      • Prepare biowaivers for post-approval changes (e.g., additional strengths, process/formulation changes).
      • Provide technical support to other departments on dissolution method and drug product release issues.
      • Ensure compliance with Code of Conduct, Business Ethics, and all legal and regulatory requirements.
      • Collaborate effectively with team members to achieve outcomes.
      • Uphold company values of Collaboration, Courage, Perseverance, and Passion.

    Job Requirements:

    Education:

    • Recognized post-secondary education in analytical chemistry, pharmaceutical sciences, or a related field.

    Knowledge, Skills, and Abilities:

    • Understanding of the new product development process.
    • In-depth knowledge of dissolution theory, method development, and validation.
    • Knowledge of pharmacokinetics and IVIVC concepts.
    • Familiarity with ICH, FDA, TPD, and other regulatory guidance documents.
    • Understanding of SOPs, GMP, GLP, and GDP.
    • Skills in wet chemistry and analytical bench techniques.
    • Proficiency in chromatographic method development and validation.
    • Excellent written and verbal English communication skills.
    • Computer literacy in Word, Excel, PowerPoint, chemistry drawing, JMP, literature search, and data generation software.

    Experience:

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

    Why Apotex: 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 contacted for an interview or testing, please advise if you require accommodation.

     

     

     

     

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