Key Responsibilities:
* Liaise with Process Science/Technology Transfer teams to transfer and start up downstream manufacturing process.
* Ensure technical input into Manufacturing records, batch sheets and procedures (MES).
* Write reviews, standard operating procedures or other controlled documents as needed.
* Provide technical input to resolve process problems on and off production suites.
* Work with cross functional groups to resolve process issues and improvements.
* Support manufacturing personnel to increase technical knowledge of critical process steps.
* Modify process method files through the quality system.
* Support CAPA implementation on process related improvements.
* Support downstream manufacturing process according to approved protocols, regulation, and schedule.
* Communicate changes to process or material used within the process to supervisors.
About You:
* You have deep technical knowledge of Downstream Manufacturing Process.
* You have experience representing manufacturing during regulatory and client audits.
* You demonstrate an ability to lead continuous improvement initiatives.
Requirements:
* Bachelor's degree in Life Sciences or related field.
* 2+ years relevant cGMP manufacturing/engineering/scientific experience in Drug Substance Biotech facility.