Senior Manager - Upstream Tech Transfer job in Geneva, Switzerland

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Job type: Permanent

Discipline: Bioprocessing

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting a Senior Manager - Upstream Tech Transfer for a pharmaceutical corporation. This role is on a permanent basis and is located in Geneva. The client is focused on producing medicines for autoimmune illnesses and oncology.

Responsibilities:

You will plan, write and evaluate the pertinent CMC sections of regulatory reports.
Responsible for serving as the technical upstream expert for regulatory consultations/interactions, which involves briefing book and report planning and replying to queries.
The ideal candidate will serve as a representative for the upstream team at various cross functional meetings both internally and externally.
Assist with upstream troubleshooting and root-cause investigation actions at the CDMO throughout Technology Transfer, GMP manufacturing, PPQ and commercial campaigns.
Evaluate and approve external technical development protocols/dossiers.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a life science or engineering field.
Fluency in the English language with knowledge in French would be beneficial for the role.
At least 7 years of pertinent work experience within a biotech organisation with the ability to upstream process for biologics, ideally with mammalian cell culture and monoclonal antibody familiarity.
Acquaintance with microbial expression systems such as E. coli, as well as biosimilars would be beneficial.
Background in upstream development spectrum, which involves process development, scale up ad tech transfer, large scale manufacturing, process characterisation and process validation.
Ability to lead and influence others while driving them to deliver.
Works well with others.
Capable of holding self-accountable.
Able to think analytically and tactically, with the capacity to review scientific data attained a various staged of development.
Capable of working on various projects simultaneously with the ability to flexibly switch between projects when required.
Willing to travel for business needs up to 20% of the time.
Capable of working well within a matrix setting.

If you are having difficulty in applying or if you have any questions, please contact James Hume at +44 208 167 5468.

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

Proclinical Staffing is an equal opportunity employer.

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