CMC Project Manager - Cambridgeshire

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  • Would suit a Laboratory Supervisor or Team Leader
  • CMC Development.
  • Permanent Opportunity
  • Competitive salary and package.

Are you a Laboratory Supervisor or Team Leader from an analytical services environment?  Zest Scientific is working alongside experts within drug development, and we are looking to identify an experienced Project Manager with an excellent understanding of the CMC development and commercial life cycle. 

The Project Manager is responsible for the establishment and management of in-house and sub-contracted CMC projects for the CMC development of drug and biologics products for the pharmaceutical and biopharmaceutical industries.

 

The role:

 

  • Maintaining an awareness of the competitive marketplace for CMC services in general and CMC programme management and consultancy in particular, to include service expectations.
  • Keeping abreast of regulatory guidelines and industry expectations and contribute to the establishment and delivery of appropriate services.
  • Ensuring that all CMC programmes/projects meet current and prospective world-wide regulatory compliance, industry guidelines and internationally recognised quality standards.
  • Acting as Programme/Project Manager, liaising with internal and external groups to ensure that the conduct and reporting of the programme/project complies with the requirements of GMP, the Project Plan and relevant SOPs and is delivered on time.
  • Ensuring an appropriate level of communication, at all levels, is maintained with clients and that status and progress reporting meet client requirements.
  • Ensuring that deliverables (including reports) meet appropriate quality and compliance standards.
  • Maintaining effective working relationships with internal providers and departments to understand their pressures and drivers and ensure effective delivery of programmes/projects.
  • Authorising Programme/Project Plans and approving reports.
  • Contributing to the overall management of the department
  • Working in conjunction with Sales and department staff, ensuring that clients receive prompt and appropriate responses to enquiries and are regularly updated with programme/project progress.
  • Assisting in providing prices for programme management activities and consultancy services.
  • Leading and contributing to meetings with client companies when they visit the department.
  • Working with collaborating departments and groups to improve interdepartmental communication.
  • Ensuring that a quality service is provided by the department, by regular discussions with internal and external customers.

The person:

 

  • Degree level
  • Experience of working in CRO or service environment in a customer facing role, ideally within a pharmaceutical analytical environment – this may have been a laboratory lead/ Team Leader
  • An excellent understanding of the CMC development and commercial life cycle.
  • Likely to have spent a number of years working in a pharmaceutical analytical environment.
  • A broad knowledge of analytical strategies and technologies for biologics.
  • A thorough understanding of GMP regulations and other applicable guidelines
  • Confident with project management tools and software

 

Key words:

 

Biologics, CMC, CMC Development, Biologics CMC Development Jobs Cambridgeshire, Laboratory Supervisor

 

Company and culture:

 

This is a permanent role with excellent salary and benefits.