Analytical Development Consultant

Highly Competitive
  1. Contract
  2. Good Manufacturing Practice (GMP)
  3. France
Paris, France
Posting date: 16 Nov 2023
57571

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

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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