Bioanalytical External Study Monitor (BESM)

Are you looking to apply your analytical skills outside of the laboratory setting? At GSK we have an opening for a Bioanalytical External Study Monitor within the Bioanalysis, Immunogenicity and Biomarkers (BIB) organization.Combining your skills as an analytical scientist with drug development and regulatory understanding you will work with external partners to deliver analytical endpoints for preclinical and clinical studies across the GSK portfolio. This role will be based at either our Upper Providence, PA, USA, or Stevenage/Ware, UK research sites.

In order to maintain a flexible workforce and focus on value added areas of support within Research, the business model within BIB includes the capability/capacity to outsource certain bioanalytical methods and analyses. The core responsibilities of the role are centered around management of all aspects of the conduct of method development, assay transfer / validation (including cross validation), bioanalytical (BA) and toxicokinetic (TK) phases of toxicology and clinical studies performed at CROs to meet the requirements of the projects and appropriate pre-agreed timelines.

For success in this role, you should lead by example in terms of day-to-day behaviors consistent with the GSK leadership expectations.You should be able to apply sound judgment to study support, to build strong working relationships within and beyond your team and strive to improve your knowledge and skills in the successful outsourcing of studies. You will hold yourself accountable for delivering quality results that are in line with the GSK and regulatory requirements.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Act as Sponsor Reviewer for BIB studies outsourced to contract research organizations (CROs).
  
• Act as the primary interface for communication between GSK and CRO staff.
  
• Work closely with CRO partners to ensure timelines for method development and sample analysis are met and communicate any delays.
  
• Coordinate and actively contribute to meetings with scientists and project managers from CROs.
  
• In partnership with GSK External Quality Assurance, evaluate third-party compliance with worldwide GLP and GCP regulations, relevant SOPs, protocols, policies and procedures.
  
• Collaborate with Procurement, internal subject matter experts and other relevant disciplines in GSK and CROs to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness.
  

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• PhD/MSc (Biochemistry, Chemistry or related discipline) preferred, however candidates able to demonstrate equivalent knowledge will be considered.
  
• Minimum of 3 years of pharmaceutical industry experience, expertise in externalization of bioanalytical work advantageous.
  
• Experience with hands-on development of LBA or LC/MS based methods to support validation of PK, biomarker and immunogenicity assays and ability to troubleshoot methodological issues.
  
• Experience with regulatory requirements for GLP and GCP analytical activities.
  

Preferred Qualifications:

If you have the following characteristics, it would be a plus :

• Detailed understanding of analysis and reporting of preclinical and clinical PK, biomarker and immunogenicity data and its context to the study/Project.
  
• Excellent communication skills - will need to interface between many functional areas including external suppliers, internal study teams, subject matter experts and Quality Assurance.
  
• Excellent attention to detail - reviewing validation plans, study plans, validation and bioanalytical reports, and assisting with reconciliation of study samples.
  
• Through understanding of the drug development process
  
• Accomplished data interpretation skills both bioanalytically as well as secondary outputs such as PK/PD, immunogenicity status, etc.
  
• Line of site to new and emerging analytical technologies
  

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  
• Continuously looking for opportunities to learn, build skills and share learning.
  
• Sustaining energy and well-being.
  
• Building strong relationships and collaboration, honest and open conversations.
  
• Budgeting and cost-consciousness.
  

*LI-GSK

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