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Pharmaceutical Development Manager από την εταιρεία Manufacturing Company

Πλήρης Απασχόληση
Αθήνα

Περιγραφή Θέσης

Branded generic Manufacturing Company is seeking for a Pharmaceutical Development Manager. 

The position is based in Athens and involves regular international travel.

Overall Purpose 
The Pharmaceutical Development Manager will play a critical role in the delivery of Manufacturing and Control (CMC) activities for projects at all stages of R&D.

Tasks and Responsibilities 
Manage  CMC activities for assigned R&D projects:
  • Establish strategies that meet project and regulatory requirements, in collaboration with the Head of Pharmaceutical Development and expert consultants
  • Develop and maintain suitable project schedules, budgets and risk mitigation plans with project teams and external service providers
  • Liaise with service providers on a regular basis to monitor progress against milestones, as well as resolve technical, quality or resource issues smoothly
  • Review and manage technical data and documentation to ensure timely action, compliant storage and efficient retrieval
  • Prepare project updates, presentations and reports for both internal and external stakeholders 
  • Prepare regulatory documentation (non-clinical and quality modules) and support regulatory submissions
  • In collaboration with the Procurement Officer, identify and evaluate potential external service providers, taking into account technical capabilities, quality requirements and cost-effectiveness
  • Organize quality agreements and audit schedules for service providers, monitor and improve their performance, and maintain a qualified service providers list
  • Maintain awareness of the contract research and manufacturing environment and relevant service offerings

Development and management of pharmaceutical quality systems:
  • Support the development, implementation, maintenance and monitoring of quality systems  to assure compliance with GLP, GMP and GDP requirements
  • Manage standard operating procedures relating to pharmaceutical quality
  • Maintain awareness of applicable guidelines and regulations

Reporting Line 
  • He/she reports to Head of Pharmaceutical Development

Job Requirements Skills and Attributes 
  • Robust knowledge of non-clinical safety studies, CMC activities, regulatory requirements, and their relationship to the drug development process
  • Strongly supportive  and understanding the organization’s values and business model
  • Demonstrated expertise in project management, applied preferably within a multi disciplinary R&D environment, with a strong track record of successful delivery
  • Substantial experience of managing international business relationships with external project partners and service providers
  • Ability to interrogate and interpret data, problem-solve, make sound decisions and recommendations
  • Capacity to plan and organize own work with autonomy
  • Competent in use of spreadsheet and planning software

Experience 
  • Minimum 3 years’ relevant experience 
  • Proven ability to work effectively in a team environment 

Education 
  • Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level
  • Degree in relevant scientific discipline (i.e. chemistry, pharmacy)

Other Requirements 
  • Fluency in English
  • Very good knowledge of Microsoft Suite

The Company offers an alluring European working environment 
With High potential of development and growth 

Κωδικός αναφοράς

Pharmac.Development Manager

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