Analytical technical expert (external CLO /CMO) – Flanders

The Company

Our Client is a multinational and innovative global healthcare company.

Their teams across the world strive to transform the practice of medicine, turning the impossible into the possible for patients. In Belgium they have 4 sites and 1500 employees.

The team

Specialty Care External Supply Quality (SCES Q) is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products.

SCES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes.

In order to reinforce their team, they are looking for an Analytical technical expert (external CMO/CLO).

You will work on the Ghent or Geel site and remote is also an option.

Responsibilities

• You are responsible for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.
• You will coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.
• You will coordinate and manage qualified materials program.
• You will coordinate/Lead multiple site/global projects and represent QC across organizations.
• You will contribute to the operation of Stability and Quality release testing programs across a multiproduct portfolio, managing timelines to meet corporate goals.
• You will execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents)
• You ‘ll generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.
• You will originate of ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product
• You will contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA;
• You will contribute to stability and quality sections of Annual Product Review Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
• You will track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews

Qualification, Education & Work Experience

• You hold a BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical /biotechnology industry.
• An advanced degree is preferred, along with experience ideally working with external partners (e.g. contract laboratories and suppliers);
• A quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers);
• A LIMS experience preferred but not mandatory;
• You have an In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment

Our client offers

• Variety in your work assignments
• Good salary package and additional conditions
• An international, dynamic and challenging workplace.
• Extensive trainings and an attractive career path
• Dynamic colleagues who like good teamwork and lots of employee activities

Our client Core Values

• Teamwork
• Courage
• Integrity
• Respect