Cmc Lead

vor 2 Wochen

Basel, Schweiz Proclinical Vollzeit

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.

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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