Sign In
 [New User? Sign Up]
Mobile Version

Lead Scientist IV Bio CMC

Covance Laboratories Ltd

Greenfield, Indiana 46140
Job Type:
Job Status:
Full Time
Covance Laboratories Ltd
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

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. 


  • 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.
Powered ByLogo

Featured Jobs[ View All ]