CMC Lead - Drug Substance (Remote)

Highly Competitive
  1. Permanent
  2. Biochemistry
  3. Switzerland
Basel, Switzerland
Posting date: 11 May 2023
54183

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

Proclinical are recruiting a CMC Lead - Drug Substance for a pharmaceutical organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Europe with occasional visits to Basel.


Responsibilities:

  • Accountable for drug substance CMC development actions from late stage to product licensure.
  • Author/evaluate and approve technical protocols and reports.
  • Offer contributions to project feasibility and suggest alterations to guarantee successful accomplishment of allocated projects.
  • You will interface with project governance committees when needed both internally and externally.
  • Assure all actions carried out are to the company's international quality and safety standards.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to an advanced degree level in a biotech or similar organisation.
  • At least 4+ years of experience in late-stage development and GMP manufacturing of pharmaceutical products.
  • Experience with regulatory leadership concerning the Chemistry, Manufacturing and Control of manufacture pharmaceutical products.
  • Familiarity with project management of multifaceted technical projects which include various shareholders both internally and externally.
  • Acquaintance with cooperating with CDMOs/CMOs.
  • Communication skills both verbally and in writing.
  • Able to think tactically, produce novel methods, drive changes, handle ambiguity as well as predict future trends and consequences.
  • Works well cross-functionally within a matrix setting.
  • Leadership capabilities.
  • Fluency in the English language with knowledge in German or Swedish would be beneficial.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at +44 203 0590923.

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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