The Bio process Expert will be responsible for technical and scientific support to manufacturing (MFG) shopfloor and will manage timely completion of MFG activities (compliance, TT, campaign preparation, troubleshooting…). Coaching of MAs regarding main area of expertise and side processes. The Process Expert will be responsible for overseeing and managing intra, cross-site, and cross-functional projects related to process and productivity improvements. The main responsibility is within management of recipe driven operations, process equipment, deviation management, changeover, tech transfer, projects (change control and CI) and direct process support as applicable.
This is a permanent role to be based in German speaking part of Switzerland. A perfect candidate is one who is open to do operational role rather than project management.
· Acts as Subject Matter Expert on manufacturing equipment and processes. Participates in Tech transfer activities as needed. Authors related technical instructions and records, including RG/RT, procedures, work instructions, and forms
· Partner with direct manager to assign appropriate resources to tech transfers, drive continuous improvement, ensure manufacturing instructions are clear, safe, and compliant..
· Initiates, owns, and manages Manufacturing focused Change Controls, CAPAs, and Planned Exceptions. Supports in generating area assessments and performs root cause investigations in DEV/AA/RAR reports in Trackwise
· Utilizes depth of experience and known precedent to identify, troubleshoot, and resolve moderately complex technical and operational problems that arise.
· Creates projects as needed to establish new manufacturing techniques to resolve day to day issues with management guidance and cross-functional buy-in.
· Proactively identifies continuous improvement opportunities, shares knowledge cross functionally, and drives site and/or global implementation. Serves as CI Practitioner role when required by cross-functional teams.
· Relevant Swiss working/residency permit or Swiss/EU-Citizenship required
· High school diploma or equivalent as a minimum. Bachelor’s degree or higher preferred. Other combinations of education and experience can be considered.
· 8-years of direct experience working in a GMP environment
· Experience in leading new Product Technology Transfer – supporting meetings, authoring manufacturing technical instructions, facilitating/coordinating reviews, and driving manufacturing technical instructions and recipe requirements to meet production timelines.
· Experience in Initiating, owning and managing more complex Manufacturing focused Change Controls, CAPAs, and Planned Exceptions driving assessments and manufacturing technical instruction requirements to meet timelines.
· 3. Must demonstrate the ability to analyze and initiate improvements to process performance. Proficient at communicating with other departments and management, especially related to large site or cross-site project initiatives that have complex impact.