90 % Remote – Expert for chemical procedures (m/f/n) – Freelance – on hold

  • Position zu besetzen ab 1. November 2021
  • Permanent-ID OCR-FL-1511
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Project description:

Evaluate chemical procedures and related conditions in the field of drug substance and drug product manufacture in order to assess potential formation of targeted classes of impurities. Each eval will be summarized in a report that will be reviewed and clarified with the customer prior to finalization.

A prioritized list of drug substances and related drug products in combination with process and other expert information and references and guidance about targeted classes of impurities are provided. The main steps of evaluation include reading the documents, noting of potential impurities (structures and processes), adding case by case additional comments and preparing a summary of the findings.

The outcome of the service work will assist to manage the customer’s chemical evaluation project for targeted classes of impurities within drug substances and drug products. It will be the basis for analytical quantification of the identified potential impurities.

 

Experience:

  • Experience as an organic chemist for a minimum of 10+ years (Master or PhD)
  • Knowhow in chemical problem solving, based on multifold project management in chemical process development to improve routes / to scale up chemicals / materials / drug substances
  • Experience in project leading and KPI tracking in pharmaceutical environment
  • Strong practical knowledge in documentation and monitoring of Pharmacy regulation processes