Senior Bioanalytical Project Manager

Remote - US, 2304 Silverdale Drive, Johnson City, Tennessee, United States of America

Lab Connect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.

We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

The purpose of the Senior Bioanalytical Project Manager, Small Molecule Bioanalysis role is to consult and provide technical expertise and project management across a range of bioanalytical activities on behalf of A4P’s contracted customers. This includes the oversight of outsourced bioanalysis at contract research organisations for clinical and pre-clinical drug development.

• Oversight and management of method development, validation and sample analysis studies at contracted CROs.
• Provide technical input in the application and operation of quantitative bioanalytical techniques.
• Provide technical and regulatory expertise on bioanalytical strategies during client meetings and ensure regular updates on progress of outsourced activities to customers.
• Interact effectively with client’s stakeholders. This will include but not be limited to outsourcing experts, data managers, pharmacokinetic and pharmacology experts, procurement and/or bioanalytical sample managers.
• Source, select and engage with appropriate bioanalytical CROs for customer outsourced activities.
• Review bioanalytical data generated by CROs.
• Review draft validation and bioanalytical analysis plans, reports and study documents.
• Ensure effective communication and management strategies with contracted CROs.
• Monitor CROs activity and KPIs as required by customers.
• Oversight of biosample operations, support to central lab set up, kit provision to sites and sample lifecycle.
• Contribute to the development of A4P and Lab Connect products and services.

This is a remote role best suited for candidates in the Eastern US. Minimal travel may be required.

• Degree/ master's level equivalent in a (bio) chemistry or similar discipline with a minimum of 10 years relevant experience in regulated bioanalysis.
• Extensive knowledge of PK / PD analysis within regulated environments (GLP / GCP).
• Comprehensive knowledge of LC-MS/MS analysis.
• Practical experience of managing and developing bioanalytical methods, assay validation and study data generation in clinical and pre-clinical studies.
• Experience in the pharma and/or CRO industry supporting regulated bioanalysis.
• Knowledge of the latest regulatory standards required for GXP studies, including international guidance published by regulatory agencies.
• Knowledge in design and operational execution of clinical and pre-clinical studies.
• Significant understanding of the research activities within a drug development organisation.
• Experience in the analysis of large molecules by LC-MS/MS.
• Knowledge of EU IVDR / FDA regulations.
• Previous experience managing contract research organisations.
• Experience of input to regulatory submissions.

• Engaging, enthusiastic, self-motivated, solution oriented, confident and a team player. Able to interact with both large global and emerging start-up organisations.
• Capable of prioritizing activities and multi-tasking across several deliverables.
• Strong attention to detail.
• Excellent verbal and written communication skills.
• Keen to learn and provide and receive constructive feedback.
  
  Able to gain client’s trust and confidence in A4P capabilities.
• Able to develop effective relationships with external service partners.
• Available to travel and work at customer site(s) for short periods of time.
• Willing to travel

All…