We are seeking an experienced professional to lead our production operations team. This is a unique opportunity for someone who wants to work in a dynamic environment where they can utilize their skills and knowledge to drive process improvements and ensure compliance.
1. Lead/Guide team members within the Production Operations team
2. Coach and develop colleagues within the Production team
3. Support team on shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure effective issue resolution
4. Lead, facilitate and participate in cross-functional teams to collaborate effectively to cover compliance topics.
5. Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects.
6. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
7. A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working.
8. Lead complex process investigations on the production floor in support of deviation resolution.
9. Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups.
10. Support team on 24/7 shift cycle and act as POC (point of contact) and POE (point of escalation) to ensure issue resolution
11. Conduct all work activities with a strict adherence to the safety and compliance culture on site
12. Participate in safety, process and environmental investigations. Review alert and action limits as needed and implement corrective action as appropriate
13. Write, review, and/or approve manufacturing documentation (SOPs, Manufacturing Records & Logbooks)
14. Ensure the effective use of material, equipment and personnel in producing quality products.
Requirements:
* Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
* 4 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
* Understanding of multi column chromatography concepts.
* Familiarity with contamination control and batch release requirements.
* Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits.
* Problem, Deviation, and Change Management experience.
* Commissioning and Qualification experience.
* Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
* Familiarity with Emerson DeltaV, SIPAT, and the use of Automation in a manufacturing Process.