CMO Project Manager at HAL Allergy
The CMO Project Manager is responsible for planning and managing the introduction of new products and/or technologies at HAL Allergy. As the key contact person for the customer, you act as liaison between the customer and the operational organization, such as Production, QA/QC and Supply Chain.
Tasks and responsibilities
- Lead projects (of internal processes and CMO projects) in order to make changes in production processes possible. Strongly interact with different stakeholders involved in the project: external customer, QA, QC, manufacturing, etc.
- Responsible for technical transfer of existing and new process technologies in production processes.
- Provides insight and guidance to current processes and new production technologies. Improve and extend existing techniques in our production processes, including consequences for the production chain.
- Ensure the transferred production processes meet GMP regulations.
- If needed, prepare validation protocols for manufacturing processes. Surveillance and execution of validation tests.
- Lead with aspects related with the projects as risk analysis, CAPA, change control, process investigations, continuous improvement etc.
Requirements
- Minimum Bachelor’s Degree.
- A minimum of 5 years of experience in the pharmaceutical industry in a relevant position.
- Experience in managing projects, preferably projects with international customers.
- Good understanding of GMP regulations.
- Good knowledge of pharmaceutical processes like filtration, formulation and freeze-drying.
Personal & Professional Skills
- Result oriented. Able to offer pragmatic solutions.
- Pro-active.
- Ability to think and act strategically.
- Ability to stimulate teams and individuals.
- Open mindset, flexible, able to adapt to different situations.
- Good communication skills.
- Proficient in both Dutch and English, both verbal and written.
