Chemistry Laboratories Manager

4 days ago


York, York City, United Kingdom Bionow Full time
Job Title: Senior Study Management Specialist

Estimated Salary: £65,000 - £90,000 per annum

Bionow is seeking a highly skilled and experienced Senior Study Management Specialist to join our team in York, UK. This is an exciting opportunity to work on regulated bioanalysis studies, utilizing your expertise to ensure efficient and effective delivery.

Key Responsibilities:

  • Act as Study Manager/Principal Investigator for regulatory and non-regulatory studies.
  • Ensure studies are conducted in compliance with company SOPs, policies, protocols, study plans, analytical methods, and regulatory standards.
  • Work to a high standard of precision and accuracy, complying with all laboratory GLP/GCP procedures.
  • Responsible for generation of Study Plans, Data Transfer Agreements, Analytical Reports, and subsequent amendments.
  • Document and complete quality documentation (Quality issue, CAPA, deviation, change control) as appropriate and within the required timeframes.
  • Address all study-related internal audit comments.
  • Act as departmental lead with Sponsor/Client/internal teams for Bioanalytical activities conducted on assigned studies.
  • Construct results tables and perform quality control review.
  • Participate in internal and external quality assessment activities as required.
  • Oversee LC-MS/MS method development and troubleshooting.
  • Provide technical, practical, and scientific direction for work conducted.
  • Ensure data is archived in accordance with company SOPs and regulatory requirements.

Requirements:

  • B.Sc in Chemistry or related subject.
  • Minimum of 6 years study management experience in regulated bioanalysis.


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