• Manager, Analytical Development

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(2/7/2019 10:06 AM)
    Job ID
    2019-1195
    # of Openings
    1
    Category
    Other
  • Overview

    The Manager, Analytical Development will be responsible for the Management day-to-day activities of an Analytical Development team comprised of one or more analytical chemists. The team’s focus is the development and validation of analytical test methods suitable for analysis of clinical-stage drug product. The incumbent will be expected to oversee method development and validation activities to support small-molecule drug substance or drug product testing which meets phase-appropriate requirements. The incumbent is expected to maintain a laboratory presence and may represent Analytical Development in cross-functional project and CMC teams. Preference will be given to candidates with strong method validation and tech transfer experience.

    Responsibilities

    • Supervise and mentor analytical chemists on their team
    • Serve as a resource for all members of Analytical Development
    • Oversee and provide technical guidance on method development and validation for drug substance, key intermediates, and drug product
    • Represent analytical department on cross- functional teams
    • Provide input to Development Management concerning Analytical Development personnel decisions, departmental budget, equipment purchase and project timelines, growth, budget, and timelines on project management
    • Oversee external outsourcing and testing

    Qualifications

    • BS or higher degree in Chemistry or Analytical Chemistry; Master’s preferred
    • 10+ years of progressively more demanding small-molecule analytical chemistry experience within the pharmaceutical or biotechnology industry
    • Prior supervisory experience is desirable
    • Hands on knowledge of instrumental analysis techniques, including, HPLC/UPLC, GC, FT-IR, KF. Other techniques (particle size measurements, NMR, GPC, LC-MS, viscometry) are a plus
    • Experience in method validation and method transfer
    • Familiarity with USP and ICH guidelines and incorporation of these requirements into method development and validation
    • Ability and willingness to work as part of a team, assisting colleagues in providing a functional, safe working environment while maximizing laboratory efficiency
    • Ability to execute controlled experiments with a strong attention to detail
    • Driven self-starter with capability to either work independently or as a part of a team
    • Comfortable working in a fast paced, high pressure environment

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