Bioassay Manager

hace 1 día

Madrid, España Proclinical A tiempo completo

Proclinical are recruiting a Bioassay Manager for a biotech establishment. This role is on a permanent basis and is located in Madrid. The client is focused on to produce a new generation of life-changing remedies for people.

**Responsibilities**:

- Evaluate implemented assay packages, which involves evaluation of chromatography data and any other analytical outputs.
- Write and/or assist with quality systems records, for example: deviations, change controls, CAPAs.
- Assist with efforts for strategic troubleshooting, remediation, change and optimisation efforts in conjunction with quality control and analytical development.
- You will perform and/or assist with technical assessments of deviations and investigations.
- Other duties may be assigned to the role.

**Skills & Requirements**:

- Educated to a degree level in a pertinent scientific field with at least 2-5 years of experience working within a cGMP lab environment, oriented around analytical chemistry and raw materials pharmacopeia testing.
- Know-how of pertinent as well as ongoing FDA, EU, ICH regulations, USP/EP/JP pharmacopeias, and guidelines.
- Know-how of tactical qualifications/validations.
- Capable of troubleshooting and discussing problems in a scientifically and comprehensible manner.
- Able to prioritise, handle and accomplish various projects and tasks simultaneously in a fast-paced work setting.
- Works well independently.
- Works well with others in an energetic, cross-functional matrix setting.
- Fluency in the English language.
- Communication skills both verbally and in writing.

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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