Key Responsibilities for Bioprocessing Specialist
Your mission is to act as a subject matter expert and responsible manufacturing specialist for an area of bioprocessing.
* Ownership and accountability for a designated bioprocessing stage, acting as site Subject Matter Expert (SME).
* Responsible for coordinating and supervising bioprocessing operators when on shift, and deputizing for Team Leader when required.
* Define training approaches for technical and support activities within Manufacturing, and oversee the quality of training execution.
* Perform manufacturing activities following all GMP instructions and good practices to manufacture products.
* Lead Quality issue rapid response during bioprocessing, and independently lead root cause analysis investigations for deviations.
* Develop and lead Quality Risk Assessments and Change Control for area of responsibility.
* Prioritize continuous improvement initiatives that address recurring deviations, process yield opportunities, and other improvements.
Requirements and Skills for Success
To succeed in this role, you will require:
* Minimum 5 years of hands-on experience in biopharmaceutical manufacturing with a strong focus on gene therapy, plasmid DNA, or viral vector production preferred.
* Comprehensive understanding of upstream and downstream bioprocessing operations including fermentation, purification, and aseptic techniques.
* Proven ability to handle quality events, manage CAPAs, change controls, and quality improvement initiatives.
* Demonstrated experience leading and mentoring a team of bioprocessing operators providing daily guidance, task allocation, and performance feedback.
* Familiarity with GMP regulations and guidelines ensuring compliance during all manufacturing activities.
* Ability to effectively collaborate with QA, QC, Technical Transfer, and other teams to support manufacturing activities and address process improvements.
Becoming part of our dedicated team would provide you with valuable experiences and knowledge in bioprocessing. If you are looking for a challenging yet rewarding role, consider joining us.