CMC Manager

Project-ID: 1253

Your activities

  • Internal coordination of all CMC activities related to drug development, regulatory affairs, and commercial stage
  • Manage all CMC documentation related to the selection and management of new suppliers
  • Interface with quality assurance of both ongoing technical and quality documentation
  • Ongoing management of individual CMOs (forecasts, contract negotiations, supplier selection, contract award, etc.)
  • Ongoing coordination of CMC activities in case of portfolio adjustments due to new FDFs or APIs
  • Preparation of all relevant regulatory and technical information
  • Ongoing process harmonization as a result of a site acquisition by a global player

Your background

  • Successfully completed degree in natural sciences (or comparable)
  • Relevant professional experience in CMC management
  • Experience in dealing with CMOs regarding regulatory or quality aspects
  • Fluency in English
  • Knowledge of German is an advantage, but not a must

Gender note

For reasons of better readability the language forms masculine, feminine and diverse (m/f/*) are used simultaneously. All references to persons apply equally to all genders.

Type of contract

Permanent

Industry

Pharmaceuticals

Department

Regulatory Affairs

Location

Berlin

Germany

Entry date

Asap

Duration

Permanent

Remote

teilweise

Capacity (FTE)

1

Your contact person

Interested?

We are looking forward to your application!

To apply, simply fill out the contact form below and attach your resume.

Your CV