Senior Biologics Lead - Late Phase CMC

We are recruiting for a Biologics Senior expert who will play a key role in the development of formulation and processes for protein parenteral dosage forms within late phase clinical or commercial use. You will also be strongly involved in the generation of CMC and other registration documents. This is a senior position and the contract is initially for 6 months, with further extensions in place. You will have 5-10 years experience in CMC development within late phases of Biologics.

Responsibilities

- You will lead and manage the drug product team of functional experts.
- You will represent Pharmaceutical Development on the CMC subteam
- Contribute to the overall design and monitoring activities within late phase biologics development.
- Generate scientific documents to hand over to internal partners (Manufacturing sites, Device Development, RegCMC, Clinics etc.).
- Actively support generation of international registration documents for market authorization and interact with authorities

Requirements

- PhD or equivalent education in Pharmaceutical Technology or Biotechnology.
- At least 5-10 years relevant experience in pharmaceutical industry
- Thorough understanding of late phase pharmaceutical development activities for Biologics and/or process engineering of sterile dosage forms as well as a generally broad scientific and strategic background
- Thorough track record of process transfer, validation and - importantly - regulatory submissions including health authority inspections.
- In-depth background in commercial manufacturing and/or technical life cycle management of Biologics drug products is of advantage.

Please contact Luchele Mendes (at the rate of) or call

Michael Bailey International is acting as an Employment Business in relation to this vacancy.