Project Manager Biologics CMC
Location: GermanySIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Rheinland-Pfalz Germany.
Our client is an international Pharmaceutical company specialized in Biologics
ROLE DESCRIPTION
- Responsible for the CMC development strategy
RESPONSIBILITIES
- QbD and QTTP
- Identification of risk
- Oversight of clinical distribution of MABs
- Oversight of CMO's
- Support packaging and labelling at external partners
- Preparation for release by responsible person
- Management of distribution of temperature controlled goods
- Set-up of SOP's
REQUIREMENTS
- Life Science degree
- CMC development experience for Biologics
- 5 yeas experience in development or distribution of clinical materials
- Expertise in Project Management
- GCP or GMP experience
- Experience in QM, Project Management and Risk Management
- Fluency in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.
