Project Lead

Key Responsibilities

• Allocation and scheduling at the micro level of laboratory resources for laboratory activities and provides project status
• Supervises staff assigned to projects and reviews timesheet to ensure that activities performed are properly entered and that the time taken to perform the task reflects what was scheduled.
• Attend study initiation meetings for their assigned studies
• Ensure Lead Research Assistants have sufficient (and qualified) reagents to perform the work
• Ensure instruments are calibrated as per SOP (balance, pipettes, cytometers)
• Follow up on deviations and note to file (ensure they are observed, initiated, impact evaluated and closed in a timely manner)
• Initiate and maintain the study binder throughout the study
• Prepare forms and worksheets for the laboratory work and ensure the review (pre and post) is performed correctly, efficiently, and in a timely manner
• Ensure expected all study samples have been received, logged, analyzed, destroyed (if applicable) or returned (if applicable)
• Understands all activities required for proper execution of lab work
• Prepare binders for QA submission
• Answer QA reports
• Assists group leaders and/or managers in their responsibilities.
• Ensure SOPs and CSPs are compliant and technically sound
• Ensure any assigned staff execute the work properly
• Provides recommendations for quality improvements as well at a technical level for excellent laboratory execution
• Ensure staff have read driving documents and are trained on method prior to performing the work
• Provide strong leadership to foster communication and promote team building
• Responsible for coaching, mentoring, training and day to day interaction with the Research Assistants

Education

• Bachelor’s degree in Biosciences or related field

Required Experience and Skills

• Knowledge of the GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) regulations.
• 1 to 2 years of work experience in the biopharmaceutical industry
• Minimum of 3-5 years of equivalent experience
• Scientific knowledge in biochemistry and immunology
• Capacity to multitask and work on multiple projects in parallel under strict time constraints and perform under pressure
• Excellent organizational skills and ability to prioritize
• High degree of initiative, sense of urgency and flexibility
• Experience coaching and training employees
• Ability to work independently as well as in a team environment
• Strong track record delivering projects on schedule and scope
• Excellent problem-solving skills
• Meticulous with great attention to detail
• Knowledge of Microsoft Office programs, specifically Word and Excel