Biopharmaceutical Process Specialist Job Description
As a Biopharmaceutical Process Specialist, you will be responsible for leading the development and implementation of processes to drive innovation in biopharmaceutical manufacturing.
Responsibilities:
* Develop and execute process transfer documentation, including media preparation and large scale bulk drug substance manufacturing processes.
* Author and review technical protocols, reports, and gap assessments to ensure compliance with cGMP requirements.
* Collaborate with Global Process Development to identify requirements for laboratory studies and support introduction of new raw materials and consumables.
* Work closely with Quality, Supply Chain, and Manufacturing Operations to implement process improvements, such as yield and cycle time reduction.
Requirements:
* Minimum 5+ years' experience in Technical Services / Process Development / Manufacturing Support.
* Technical and operational knowledge of multiple unit operations in cell culture processing.
* Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
* Experience of Technology Transfer activities is advantageous.