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Job type: Permanent

Discipline: Manufacturing

Location: Switzerland

Proclinical are excited to announce the role as a Senior Manager Process Development & Manufacturing Sciences Life Cycle at a global healthcare company based in Nyon. This organisation specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.

Job Responsibilities

Oversee and be responsible for the responses to questions from regulatory authorities for Process Development in coordination with the appropriate expert
Lead the authoring, reviewing and editing sections of dossiers
Ensure source documents that are generated during process development activities meet the requirements of future submissions
Drive best practice to ensure efficient and timely response to regulatory questions from within Process Development
Critically review information that is used to write sections of regulatory submissions
Liaise with functional heads to develop a portfolio of topic specific templates with contents that are aligned with Regulatory expectations
Build and sustain transparency with SMEs to ensure engagement within the Process Development teams
Develop and maintain scientific expertise in Biosimilars development including up-to-date knowledge of relevant CMC regulatory guidelines and requirements

Skills and Requirements

B.Sc. (Hons) in pharmacy, biotechnology, biophysics, biochemistry or similar
Fluency in English; German and/or French would be beneficial
Minimum 8 years in pharmaceutical/biotech company specializing in process development activities; preferably with at least part in a manufacturing setting
Previous experience working with biosimilars would be an advantage
Proven ability to rapidly understand experimental procedures, data, and concepts related to development of biosimilars
Proven ability to assimilate information from key stakeholders to quickly generate outlines, content, and draft documents ready for review
Experience supporting a BLA/MAA filing and knowledge of submission writing styles is required Knowledge of good document management practices should be demonstrated Familiarity with the FDA and ICH guidelines required

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Luke Saner at +443300524502 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies

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