Cmc Project Manager

7 days ago


Cambridge, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

Walker Cole is searching for a CMC Project Manager to join a clinical stage biotechnology company specialising in small molecules. As a CMC Project Manager, you will be responsible for providing chemistry and manufacturing support to expand the preclinicaland clinical asset portfolios.

Role responsibilities include:

- Technical CMC oversight for chemistry, formulation and manufacturing of injectable, sterile dosage forms.
- Support the ongoing external manufacturing and development of clinical supplies (IMP).
- As the CMC Project Manager, you will be lead CMC regulatory requirements.
- Provide process development and scale-up expertise to ongoing projects.
- Partner and lead CRO relationships for product development activities.
- BSc, MSc or PhD in Chemistry.
- Industry experience in the pharmaceutical sector.
- Extensive process development, CMC, Technical Operations work experience.
- Technical understanding of APIs or Chemistry Drug Products (Oral Solid Dose, Inhalation, Sterile Liquids)

CMC Project Manager | Small Molecule | Chemistry | Drug Product | Drug Substance | Technical Operations Manager | Chemistry Process Development | Process Chemistry | Scale-up



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