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Expert Formulation and Industrialization of Anti-Sense Oligonucleotides

Il y a 2 mois

Gidy, Centre-Val de Loire, France Servier Temps plein
About the Role

As a key member of our team at Servier, you will play a crucial role in the formulation and industrialization of anti-sense oligonucleotides. Your expertise will be instrumental in developing and implementing innovative solutions to drive the success of our products.

Key Responsibilities
  • Formulation and Process Development: Establish the formula and manufacturing process for our anti-sense oligonucleotides, ensuring compliance with regulatory requirements and industry standards.
  • Manufacturing Coordination and Control: Oversee the production of development batches, provide technical support during clinical manufacturing, and ensure seamless scale-up and industrialization.
  • Protocol and Report Writing: Develop and approve protocols and reports on study results, ensuring consistency with project objectives.
  • Result Verification: Verify the consistency of study results with expected product specifications.
  • Collaboration and Knowledge Transfer: Provide training and support to colleagues, ensuring the transfer of knowledge and expertise.
  • Technical Support: Offer assistance to technicians and operators as needed, and conduct or oversee galenic testing.
  • Supply Chain and Inventory Management: Oversee information, procurement, storage, and manufacturing of products for user needs.
  • IMPD and Regulatory Document Preparation: Synthesize and write the galenic section of IMPD and AMM submissions.
  • Scientific and Technological Monitoring: Stay up-to-date with scientific and technological advancements in materials, technologies, and equipment.
  • Quality Procedures: Familiarize yourself with and apply quality procedures in your area of action.
  • Anomaly Handling: Investigate and treat anomalies (deviations, OOS, OOE, OOT), and inform the Quality Department for evaluation.
  • CAPA Support: Accompany business stakeholders in advancing corrective and preventive actions (CAPA).
About You

We are looking for a highly skilled professional with a strong background in formulation and industrialization of anti-sense oligonucleotides or RNA (siRNA, mRNA). Your expertise should include:

  • A degree in Pharmacy, Chemistry, Engineering, or a PhD in a relevant scientific field.
  • A minimum of 5 years of experience in the pharmaceutical industry, with experience in registering documents or regulatory clinical documents, and galenic formulation of anti-sense oligonucleotides or RNA (siRNA, mRNA).
  • Proficiency in drug delivery and formulation technologies, including drug targeting, dissolution rate enhancement, and formulated compounds such as antisense oligonucleotides, RNA (siRNA, mRNA), and/or polymer-API conjugation and/or antibody-drug conjugate.
  • A proven track record of proposing improvement actions to increase performance and provide innovative solutions.
  • Excellent teamwork and communication skills, with the ability to work collaboratively and share knowledge.
  • A commitment to ongoing learning and professional development.
About Servier

Servier is a global pharmaceutical company driven by a unique governance model, with a strong commitment to social responsibility and a vision for a sustainable future. Our team is passionate about making a positive impact on patients' lives and contributing to the advancement of therapeutic progress. We offer a dynamic and inclusive work environment, with opportunities for growth and development, and a strong focus on employee well-being.