Project Manager (Clinical & GMP Manufacturing)

Role Description

 

Project Manager (Clinical & GMP Manufacturing)

 

The Role

 

Our client provides integrated and bespoke API (Active Pharmaceutical Ingredient) manufacturing service to the pharmaceutical industry, which includes comprehensive scientific support. These clients are truly global and can range from small niche biotech companies to Global Top 20 Pharma Companies.  These products are used by our clients in toxicity trials and Clinical Trials in order to demonstrate the safety and efficacy of new drugs prior to commercial approval. Our client has successfully transitioned from their historic core market (Clinical Products), into manufacture of Commercial Products.

 

This has created the fresh challenge of managing both types of products on behalf of clients concurrently, within a busy manufacturing schedule. To meet this challenge, the new role of “Commercial Products Manager” has been created; this individual will be the high level champion of all activities related to Commercial Products and will ensure these activities are given the appropriate focus and priority within the delivery portfolio.  

 

The role holder will be integral in overseeing, coordinating and driving all aspects of Commercial Projects and Commercial Product manufacturing and will successfully manage the relationship the customer. Internally, they will project manage a multi-disciplinary team to ensure that work is completed in line with customer agreements, with a view to maximising performance.

 

Essential Criteria

 

  • Degree (or equivalent) in a Life Science related discipline
  • Extensive project management experience within a GMP manufacturing environment
  • Previous experience in a technical (Analytical), QA or Manufacturing role
  • Ability & capacity to progress an extensive amount of activities in parallel
  • Ability to deliver through influence rather than simply through line management authority
  • High level of technical capability and appreciation of the activities associated with process development, manufacturing and analysis

Desirable Criteria

  • Direct GMP manufacturing operations experience
  • Late phase and commercial API project experience

 

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