Scientific Director - Bioanalytics in Saint Charles, MO at Apex Life Sciences

Date Posted: 8/4/2018

Job Snapshot

Job Description

Scientific Technical Director

Position Summary          

The Scientific Technical Director develops client, scientific and regulatory relationships (existing and new) and provides guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant manner. Scientific Technical Directors present proposals to clients (for new clients and new services) and address any concerns from clients.

This Scientific Technical Director position is primarily responsible for:

  • Engaging existing and new clients to expand client relationships
  • Consulting with the clients to properly scope client projects and assure that scope of work meets regulatory guidelines and industry standards
  • Presenting at symposiums, conferences, and other relevant industry meetings to grow the awareness of the Eurofins offerings
  • Engaging the Project Teams to educate and hand-off the knowledge of the signed projects
  • Consulting with the Project Teams when technical issues arise during the execution of the project

Essential Duties and Responsibilities:

  • Develops client scientific and regulatory relationships (existing and new)
  • Provides guidance and oversight for compliance and scientific integrity of the studies to ensure that studies are performed in a compliant manner
  • Defines scope of work, focus of the project and consultation to the client
  • Defines the appropriate technical approach to accomplish the clients requirements
  • Provides Program Managers with scope of the work, estimates of time required to complete the project, level of technical challenges for expectation setting and scientific input for use in proposal preparation.
  • Presents proposal to clients for new clients and new services and address any concerns from the client
  • Proposes the expertise needed for the Study Directors, Principal Investigators (GLP) or Scientific Director (GCP and GMP) and Lead Scientists (for assay development studies) for each client study based on the client requirements and experience with the client
  • Serves as Study Director, Principal Investigator or Scientific Director or Lead Scientist as needed
  • Accountable for sign off of validation plans and reports as provided by the validation team.
  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Owns the accountability and responsibility of delivering to client needs and timeliness
  • Provides cross-functional support to other departments as required

Education/Experience (BMQ):  

  • PhD or Masters degree in a biological science, or equivalent experience
  • At least 12 years relevant experience in pharmaceutical industry and/or CRO or similar
  • Demonstrated success in client interaction, proposal development and sound project plans, presentation to clients at VP and higher levels and develop client relationships
  • Demonstrated experience in working effectively with business development, sales and customer service organizations
  • Experience in managing and leading cross functional teams effectively
  • Excellent interpersonal, verbal and written skills, including ability to prepare detailed scientific reports and group presentation
  • A working understanding of international regulatory requirements including MHRA and FDA GMP, GCP and GLP and a proven mechanism to stay relevant on such requirements
  • Demonstrated ability to work independently and without instruction
  • Appropriate technical expertise in relevant laboratory techniques

Supervisory Responsibility:       

This position does not typically have direct reports. However, this position has oversight for activities conducted by various personnel, including laboratory analysts, technical writers and Program Managers.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.