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Job Details

CMC Project Manager - Clinical Stage Biotech

Company: Barrington James Europe
Location: Germany
Reference: EM-CMC-PM
Closing Date: 23 Feb 18
Type: Permanent
Salary (£): Competitive
Benefits: Competitive

Job Summary:

CMC Project Manager - Clinical Stage Biotech - Germany

Requirements:

I am currently partnered with a clinical stage biotechnology company that are focused on developing innovative immuno-oncology therapeutics for the treatment of cancer and other malignant diseases. The organisation has been established for over 10 years and in this period have received over €90 mil. funding from various sources due to the groundbreaking compounds they have in the pipeline which are rapidly progressing through the pipeline.

Due to the success in their portfolio, they are looking to hire a range of experts, one of which is a CMC Project Manager who will be focused on late-stage development projects.

Responsibilities:

  • Working on late-stage CMC development projects with a focus on process validation and market preparation.
  • Support external production during CMC process development, scaling-up, stability batch manufacturing, compatibility testing and process validation.
  • Preparation and periodic adaption of CMC project plans based on feedback of relevant project team members.
  • Plan and track CMC (Chemistry, Manufacturing and Controls) activities regarding timelines, resources and costs.
  • Clinical trial supply management for (pre-)clinical studies
  • CMC contact for internal teams (R&D, Pre-clinical and Clinical Development, Regulatory Affairs, QM) and external vendors, CMOs and laboratories.

Experience Required:

  • A relevant Life Sciences degree.
  • At least 3+ years of professional experience in project management within the pharmaceutical industry with a focus on CMC activities
  • Knowledge of pharmaceutical product development processes and regulatory procedures (EU/USA), especially in the area of CMC development of biologics
  • Fluent in English and German, both written and spoken

I work on a range of interesting positions in Regulatory Affairs that are available within the pharmaceutical industry. I can provide career advice whether you are looking or not, please reach out to me on 01293 776644 or email me on emaynard@barringtonjames.com.

Apply for this job: CMC Project Manager - Clinical Stage Biotech

Contact Information:

Address:  Head Office
Rowan House Smallfield Road Horley Surrey
RH6 9AU
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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