Bausch Health

  • Manager, R&D (Analytical - Generics Development)

    Location US-NY-Rochester
    Job ID
    12313
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The Manager/Senior Manager, Analytical Development will support the analytical development function generic portfolio of product development candidate(s).  The individual will have responsibility for the oversight of internal / external analytical development activities pertaining to drug substance process and drug product formulation development, and product characterization.

    Responsibilities

    • Manages the development, validation and implementation of appropriate analytical methods in support of drug substance and drug product development across all stages of development.
    • Manages the method transfers and implementation of appropriate analytical methods in support of drug substance and drug product in internal and external laboratories/partners.
    • Manages the technical oversight, and timeline of analytical activities in alignment with program objectives.
    • Applies technical expertise to support the development of new formulations, and manufacturing processes with appropriate analytical characterization and testing methods.
    • Ability to analyze results and methods, solve analytical problems, and meet regulatory expectations for analytics applied to drug substances and drug products.
    • Assist in the drafting and review of technical and GMP documents (e.g., analytical protocols, reports, SOPs) as well as supporting the preparation of CMC documents for regulatory filings.
    • Reviews and approves protocols and reports.
    • Prepares method transfer/validation protocols and reports, and analytical data sets.
    • Identify and implement new techniques and instrumentation to expand internal capabilities
    • Manage outside resources as required such as contractors and contract laboratories
    • Proposes and justifies specifications for drug substance and drug product

    Qualifications

    • MS or PhD in Analytical Chemistry, Pharmaceutical Chemistry or related field, with 10+ years of experience in analytical development or 7+ years of experience in pharmaceutical development.
    • Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practices
    • Experience with chromatography data systems and laboratory information management systems.
    • Experience building relationships with and working with CMOs
    • Working knowledge ICH quality guidance and FDA drug manufacturing regulations
    • The position will require an ability to adapt to changes in priorities on short notice and will also require an ability to make decisions, independently, under tight timelines.
    • Ability to travel and work a flexible schedule to accommodate program priorities as needed

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