Senior Manager Process Development & Manufacturing Sciences
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.
- 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
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