Bioanalytical Team Lead

4 weeks ago

York North Yorkshire, United Kingdom Pivot Search Full time

The key responsibility of a Small Molecule Study Manager Team Lead is to serve as a Study Manager for both regulatory and non-regulatory studies. In addition, the Team Lead will directly manage a team of Study Managers.

Requirements:

  • BSc in Chemistry or related subject (required)
  • 5+ years study management experience in GLP/GCP bioanalysis
  • Management of 10+ studies at any one time
  • Demonstrated ability to handle escalations

RESPONSIBILITIES

Study Management.

  • Ensure studies adhere to company SOPs, policies, protocols, study plans, analytical methods, and regulatory standards.
  • Act as the departmental lead in Bioanalytical activities, collaborating with Sponsor/Client/internal teams for assigned studies.
  • Oversee LC-MS/MS method development and troubleshooting.
  • Review protocols, study plans, reports, SOPs, or scientific papers as needed.
  • Monitor study-specific budgets and operational costs effectively.
  • Contribute to the generation of proposal amendments as necessary.

Leadership.

  • Ensure effective performance management for teams and individuals, including clear definition of roles, responsibilities, and objectives.
  • Manage instances of below-standard performance or behaviour according to appropriate procedures.
  • Provide leadership to facilitate the effective performance of teams and individuals, ensuring alignment with monthly operational schedules and meeting company commitments and client expectations.
  • Keep management and the Site Leadership Team fully informed in a timely and transparent manner about day-to-day operations, progress toward established goals, and any deviations from company objectives.

Quality.

  • Document and complete quality documentation, including Quality Issues, CAPA, deviation, and change control, within specified timeframes.
  • Take the lead in updating procedures and organizing necessary training in response to changes or updates to regulatory and industry standards affecting the department.
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