Biotech Transfer Specialist
Join our team of experts in process development, responsible for the transfer and maintenance of biotechnology products. The role involves working with global teams to develop processes and ensure regulatory compliance.
Responsibilities:
* Provide technical support to new product introductions (NPI) and lifecycle management (LCM) changes from a Process Development perspective.
* Support process validation protocols and assessments from a quality system documentation perspective.
Requirements:
We are seeking an experienced professional with:
* A Third level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem solving ability and excellent oral and written communications skills.
Preferred Qualifications:
Doctorate or Masters in Science or Engineering.
Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
About this role:
This is an exciting opportunity to join our company as a Biotech Transfer Specialist. As a key member of the Process Development team, you will play a critical role in ensuring the successful transfer of biotechnology products.