Bioanalytical Manager

MCS Group is proud to be working with one of the top 20 global pharmaceutical companies, to recruit a Bioanalytical Manager to join their growing team.

You will be responsible for leading the clinical laboratory to support the development of pharmaceutical products in our state-of-the-art facilities.
Overseeing the development, validation and application of bioanalytical methods to clinical and preclinical studies using techniques such as LC-MS/MS, HLPC/UPLC and other advanced bioanalytical tools used.

You will ensure that the laboratories operate in compliance with GLP (Good Laboratory Practice) and other regulatory requirements (e.g., FDA, EMA, VICH) and will contribute to the successful submission of regulatory filings.

Main Activities/Tasks

• Lead, mentor and manage the Bioanalytical Laboratory Team Leads.
• Allocate resources and manage workflow to ensure project timelines are met.
• Foster a collaborative and high-performance environment.
• Work on a diverse scope of projects and provide scientific, technical, operational and compliance expertise.
• Oversee the development and validation of bioanalytical methods (e.g., LC-MS/MS, HPLC, UPLC).
• Ensure methods comply with international regulatory standards and are fit for purpose in drug development.
• Provide expertise to troubleshoot and resolve complex technical and scientific issues related to bioanalytical methods.
• Plan and manage bioanalytical studies to support preclinical and clinical development.
• Coordinate sample analysis from biological matrices (e.g., blood, plasma, tissues) for pharmacokinetics (PK) and residue profiles.
• Ensure timely delivery of high-quality data to internal and external stakeholders.
• Ensure compliance with GLP (Good Laboratory Practice) and other relevant regulations.
• Oversee preparation of bioanalytical study reports and method validation reports for regulatory submissions
  
  

Essential Criteria:

• Vast experience in bioanalytical method development and validation within the pharmaceutical/biotech industry.
• Experience with working on multiple projects with a strong cross functional component
• At least 5+ years of people management with proven track record to motivate the team to meet project deliverables and timelines
• Strong leadership and management experience in bioanalytical laboratories.
• In-depth knowledge and expertise of bioanalytical techniques, including LC-MS/MS, HPLC, UPLC and other methods.

What's in it for you?

• Competitive salary (DOE)
• Subsidised Canteen
• Discount on car insurance
• 32 days of Annual Leave
• Life Assurance
• Company Pension Scheme
• Health care Cash Plan
• Development and growth opportunities
• On-site free car parking... and many more benefits
  Full details will be provided upon application.

To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Amy Wallace, Specialist Consultant at MCS Group 028 9049 0898

Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs

All conversations will be treated in the strictest of confidence.

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