CMC Director

JR United Kingdom
Slough
9 months ago
Applications closed

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Senior Director, Biological Analytical Development (Remote / Home Based)

Senior Project Manager, R&D: Drug Development

Project Leader - ADC Biologics

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The CMC Director will provide strategic leadership and oversight for all CMC activities, from early-stage development through commercial manufacturing, for pharmaceutical drug products. This is an initial 16 month contract with the view to extend. All applicants MUST be situated in Europe. The opportunity ison-sitein Switzerland.

Responsibilities:

  • Develop and implement integrated CMC strategies aligned with overall business goals, timelines and budgets
  • Lead CMC teams across process chemistry, analytical development, formulation development, manufacturing, quality, regulatory affairs, etc.
  • Oversee development, qualification, validation, tech transfer and manufacturing of APIs and drug products
  • Ensure manufacturing processes, test methods, facilities, equipment and materials comply with cGMP regulations
  • Author and critically review regulatory documentation like INDs, NDAs, DSURs, CMC sections, etc.
  • Interact with regulatory agencies on CMC and quality topics
  • Drive continuous improvement initiatives to enhance efficiency and reduce costs
  • Implement new technologies to improve manufacturing and supply chain capabilities
  • Manage capital projects for new facilities, equipment, systems, etc.
  • Select and manage relationships with contract manufacturing organisations
  • Ensure robust supply chain and inventory management for APIs and drug products
  • Develop budget and resource plans for CMC activities
  • Mentor and develop team members in CMC group

Requirements:

  • BS/MS in chemical engineering, chemistry or related field
  • 10+ years experience in pharmaceutical drug product development
  • Deep knowledge of cGMP regulations and industry best practices
  • Leadership skills with ability to influence cross-functional teams
  • Excellent communication and problem-solving abilities
  • Understanding of pharmaceutical quality systems and regulatory compliance
  • Knowledge of drug manufacturing processes, analytical methods, quality control testing, etc.
  • Experience with regulatory submissions and agency interactions

This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply immediately as it is likely that recruitment will close prematurely.


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