Analytical Development Consultant

Proclinical are recruiting for an Analytical Development Consultant to join a biotech organisation. This role is on a contract basis with the ability to work remotely from anywhere in France.

Responsibilities:

• Handle analytical development projects with both internal and external teams, such as CMOs/CDMOs and external analytical labs.
• Arrange outsourced actions with subcontractors or partners.
• The ideal candidate will elaborate and drive analytical development plans such as planning, deadlines, etc, as well as contribute to linked development project team meetings.
• Author and evaluate protocols and study reports.
• Offer scientific knowledge to development/research projects and throughout investigations on deviations, change control requests or OOS outcomes.
• You will prepare and evaluate registration files such as IND, IMPD, BLA, etc. as well as answer to authorities.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Educated to an advanced degree level in an analytical science, biochemistry, bioanalysis or biotechnologies field.
• Fluency in the English language.
• Communication skills both verbally and in writing.
• Demonstrable experience in a similar role.
• Knowledge of protein analytical assay, protein characterisation and stability testing.
• Expertise in pharmaceutical procedures development implemented t therapeutic proteins.
• Know-how in project management and subcontractor management.
• Capable of authoring protocols and reports.
• Know-how of analytical regulations such as GMP, ICHQ2R1, Bioanalysis, PDA57, etc, as well as regulatory setting.
• A courageous, curious individual who can be transparent, follow through and build trust.
• Works well with others in a team.

If you are having difficulty in applying or if you have any questions, please contact Connie Prince at +44 203 398 5827.

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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