Covance

  • Lead Scientist IV Bio CMC

    Job Location(s) US-IN-Greenfield
    Job Number
    2018-17788
    Job Category
    Scientific Advanced Degree
    Position Type
    Full-Time
  • Job Overview

    Lead Scientist IV

    Play a pivotal role in the drug development process and grow your career.

    Bringing new medicines to market requires bold ideas. That’s why we empower our exceptional people with mentoring, in-depth training and tailored career planning. You’ll have the opportunity to own your career journey and develop alongside supportive, industry leaders who are passionate about your individual success. At Covance, you’ll discover your own extraordinary potential as you explore diverse projects and unique career paths across the drug development spectrum.   Join us and discover your energized purpose as we transform possibilities into reality for our clients—and your career.                                                                                                 

    Working as part of the Molecule Management Group, the Lead Scientist (LS) routinely manages large, multi-technique projects. In this role the Lead Scientist will:

    • Provide internal and external Clients with a central scientific point of contact for projects within Biopharmaceutical CMC Solutions – Large Molecules (BioCMC).
    • Be accountable for leading the scientific teams to ensure that Client requirements and deliverables are met. This involves discussion with the Client to design proposals, working with the PMO, communicate with the QC section managers and oversight of scientific progress of projects to ensure the successful, initiation, planning, execution, monitoring and completion of projects.
    • Navigate the regulatory framework to ensure that the client programs are conducted to meet the defined milestones along the drug development pathway with scientific integrity.
    • Must have a working knowledge of all methodologies for a Client project. They will write protocols and reports using the QC scientist approved data that fulfils the protocol design and all regulatory expectations.
    • The LS will be required to communicate with internal and external project teams, departmental management and the Client to ensure effective scientific progress throughout the life cycle of a project in partnership with the PMO. The LS will be expected to communicate the scientific and regulatory framework of a project that builds a team to understand and delivers the drug development milestones. 

    What we’re looking for

    • A Scientific degree BSc and 10 years of relevant industry experience / PhD and at least 5 years relevant industry experience in CMC Drug Development.
    • A working knowledge of a wide range of CMC analytical techniques.
    • Working knowledge of statistics and its application to techniques and regulatory applications (validation, equivalence).
    • The ability to get things done by influencing others (both internal and external).
    • An up to date knowledge of regulatory guidelines and their application.
    • Knowledge of capabilities and expertise of the Covance organization and companies that may provide support services.

     

    Thrive personally and professionally at Covance

    Working at Covance, you’ll continue to grow in our learning-based culture so you’ll know how to expertly respond and adapt as the industry continues to evolve. Here, you’ll put your education to work as you play a meaningful role in advancing healthcare.

     

    We offer a comprehensive benefits package. This includes 21 days of personal time off, 7 paid holidays, medical and dental insurance as well as tuition reimbursement, a 401(k) plan with a generous company match, along with short and long-term disability and life insurance.

     

    Get to know Covance

    Covance, the drug development business of LabCorp, is the world’s most comprehensive drug development services company. Because of our broad experience, from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team’s impact on healthcare is remarkable. Through their everyday work they’ve supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.

     

    The Covance team is driven by an energized purpose to improve health and improve lives across the globe. Here, you’ll work alongside exceptional people who each play an important role in bringing new scientific discoveries and therapeutic area advancements to life. And, because we span the drug development spectrum, you’ll directly impact a wide-range of initiatives as you explore unique career paths and discover your extraordinary potential.

     

    Get ready to make a difference as we speed the delivery of groundbreaking therapies and improve lives of countless individuals.

    Education/Qualifications

    • A Scientific degree BSc and 10 years of relevant industry experience / PhD and at least 5 years relevant industry experience in CMC Drug Development.

    Experience

     

    • A working knowledge of a wide range of CMC analytical techniques
    • Working knowledge of statistics and its application to techniques and regulatory applications (validation, equivalence)
    • GMP experience is a must.
    • The ability to get things done by influencing others (both internal and external).
    • An up to date knowledge of regulatory guidelines and their application.
    • Knowledge of capabilities and expertise of the Covance organization and companies that may provide support services.

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