Senior Laboratory Manager

4 weeks ago

York, York City, United Kingdom Bionow Full time

Job Title: Sr. Study Manager Small Molecule

Department: BioA

Location: York, UK

Schedule: Days; Monday – Friday

Sign On Bonus: Up to 25% Sign-On/Relocation Bonus Available

SUMMARY

At Bionow, we are seeking a highly skilled and experienced Study Manager to lead our bioanalytical services team. The successful candidate will be responsible for managing studies in compliance with company SOPs, policies, protocols, study plans, analytical methods, and regulatory standards.

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 and comply with all the laboratory's GLP/GCP procedures.
  • Responsible for generation of Study Plans, Data Transfer Agreements, Analytical Reports, and subsequent amendments.
  • Document and complete any quality documentation (Quality issue, CAPA, deviation, change control) as appropriate and within the required timeframes.
  • Responsible for addressing 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 all data is archived in accordance with company SOPs and regulatory requirements.
  • Review any protocol, study plan, report, SOP, or scientific paper as required.
  • Be fully knowledgeable with the current concepts and principles of GLP, GCP, and COSHH.
  • Follow the company's Standard Operating Procedures (SOPs) and maintain individual training file.
  • Take lead regarding procedural updates and training required in response to changes/updates to regulatory and industry standards.
  • Communicate effectively with team members and discuss ideas in an open and professional manner.
  • Manage schedules and commitments effectively and efficiently.
  • Promote best practices within working area(s).
  • Drive the ACM Mission, Vision, and Core Values with every interaction.
  • Foster a culture that promotes quality, safety, ethical practices, customer focus, and service.
  • Support the effective performance of the team and individuals to ensure monthly operational schedules are executed in line with ACM commitments and client expectations.
  • Monitor study-specific budgets and operational costs.
  • Ensure management is fully informed, in a timely manner, about day-to-day operations and any deviations from the goals.
  • Own operational improvements and implement measures for better compliance, productivity, and profitability.
  • Understand the ACM business and scope of work in relation to the cost of the study.
  • Support new business development activities as required.
  • Work closely with Commercial and Management teams to drive new business.
  • Recognize issues and potential issues and make correct decisions on how to resolve/prevent.
  • Lead team through the process of change and address obstacles and resistance.
  • Drive process improvements.
  • Develop and train junior team members. May act as Line Manager for junior team members.
  • Collaborate and integrate with the wider ACM organization.

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