JOB DESCRIPTION

Summary:

Independently design and develop methods, and complete complex lab work, sample analysis, validation, and method development.


Education, Experience, and Skills Required:

  • BA/BS or higher with 13-15 years lab experience; all experiences will be evaluated
  • PhD in relevant field with 6-9 years lab experience
  • Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11,
  • GDP, GMP
  • Able to independently develop and perform complex lab work
  • Able to work in a regulated environment
  • Able to work effectively and contribute within a team
  • Able to work with computer systems
  • Able to document clearly
  • Able to communicate clearly
  • Knowledge of and experience in a regulatory environment


Competencies:

  • Adaptable
  • Exactness
  • Flexibility
  • Collaborative
  • Effective Listener and Communicator
  • Capacity to Master and Influence Others
  • Results Driven
  • Creative and Forward Thinking
  • Initiative
  • Supportive
  • Extend Assistance
  • Strategic Minded
  • Problem Solving
  • Innovative
  • Analytical Thinking
  • Forward Thinking
  • Client Service Oriented

 

Essential Function:

  • Prepare reagents, standards, and control samples
  • Analyze samples using various techniques specific to department
  • Independently design and develop methods
  • Perform method validation or qualification
  • Operate analytical equipment
  • Technical resource for troubleshooting activities; assays and equipment
  • Maintain analytical equipment
  • Review, evaluate, and interpret data results
  • Draft and present posters/presentations
  • Train and mentor lower level Scientists
  • Collaborate with clients and vendors
  • Ensure lab area is clean and inspection ready at all times
  • Remove lab waste
  • Collaborate across teams, departments, and sites
  • Evaluate and establish processes to improve quality and efficiency
  • Record tasks in accordance with Good Documentation Practices (GDP)
  • Knowledge of regulatory requirements; GLP, GCP, 21CFR Part 11
  • Follow applicable SOPs and procedural documents
  • Participate in site/department/global projects
  • Other tasks as assigned

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