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CMC Project Leader - Headquarter - New team

Business Type: Pharmaceutical Company
Job Type: Biotechnology, Oncology, CMC, Project Management
Job Level: Experienced (non manager)
Position: Full Time
Location: France
Reference: CK457.4
Closing Date: 13/02/19
Job Details:

Nonstop Pharma, European recruitment agency specialized in the pharmaceutical industry, is currently looking for a CMC Project Leader on behalf of an international organisation aiming to further advance towards their goal of becoming a key player in oncology. With a proven expertise in other therapeutic areas and a strong international presence, the company reinvest 25% of its turnover in Research and Development, using profits for growth.

Due to their strategy and ambition, the head of CMC created various roles to build a new team based in their headquarter. The successful candidate will have the opportunity to act as a champion of their development programs by delivering innovative solutions to challenging problems in a stimulating organizational and scientific environment.

The position of CMC Project Leader is of the highest importance within the core teams of biologics-based R&D projects. As such, you will be responsible for:

- The management and successful completion of the CMC activities related to the assigned project(s). It includes product, process and method development, manufacturing, validation and filing activities. Communication and leadership skills as well as strategic thinking are key for this position.
- The management of multi-disciplinary teams (pharmaceutical development, drug substance and drug product manufacturing, analytical development and quality control, quality assurance, Regulatory) for their Novel Biological Entities R&D programs.

Key responsibilities (non-exhaustive):

- Build and optimize the global CMC development plan with the CMC team members, according to the project objectives.
- Manage all activities and action plans in line with QCD commitment.
- Follow the CMC review cycle, highlighting main variances against the QCD commitment, initiating corrective actions
- Participate to Core Team meetings, and in particular to Risk Sessions for risks that are in his scope.


- Masters and/or Doctoral degree preferred in Biology, Biotechnology, or Chemistry
- Fluent in English is mandatory. Fluency in French is a plus but not discriminatory
- At least seven (7) years of pharmaceutical (or related) industry experience required, in an international environment
- At least three (3) years leadership and project management experience
- Experience as a contributor or as leader in several Novel Biological Entities CMC projects (recombinant proteins, monoclonal / bispecific antibodies, antibody-drug conjugates, etc.)

If you are interested in this vacancy, please contact Chloé Khatcherian on 0033 1 76 75 33 40 or send your CV in Word
format to

Posted: 06/02/2019 | NPJ Ref: 230001
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