As a leader in Biopharma Downstream Operations, you will be responsible for providing technical direction and troubleshooting guidance to the manufacturing team. Your expertise in ensuring deviation investigations, change controls, and CAPA's are delivered to a high standard and on time will be invaluable.
Key Responsibilities:
* Ensure all deviation investigations, CAPA's and change controls are delivered to a high standard and on time
* Maintain accurate and current documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) in accordance with regulatory requirements
* Support technology transfer of recombinant proteins from one site to another
* Lead investigations into process variances according to site procedures
* Implement contamination-free programs to ensure highest process success rates
* Represent manufacturing during regulatory and client audits
Requirements:
* Expert knowledge of Biopharma Downstream Operations
* Strong knowledge of industry practices and regulations
* Proven leadership skills with ability to train, mentor and lead employees
* Ability to operate in multifaceted environment and work independently or as part of a team
* Integrity and honesty at all times
This is an exciting opportunity to join our organization and contribute your skills and experience to our manufacturing team.
We are committed to maintaining a workplace culture that values diversity, equity, and inclusion. If you share our vision and values, we encourage you to apply.