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Last Name*

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First Name*

Last Name*

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: France

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.

#LI-CP1

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