Raphael Ayuk-Takem

About Raphael Ayuk-Takem

A Pharmaceutical leader with 20 years of increasing responsibility within Pharmaceutical…

Experience

1. Technical Steward Lead Life Cycle Management Project Lead (Associate Director Level)

   Novartis

   May 2012 — Present

   Report to Director of Manufacturing Science and Technology- Manage Manufacturing Execution System (MES) personnel, Process Experts, Product Stewards and consultants on Life Cycle Management (LCM) and/or Cross Validation projects. Six (6) direct reports- Support Validation Lead / Validation Experts with the creation of Validation Protocols and reports- Lead Transfer of technology projects from different sites (ANDA and Commercial). Lead projects in remediation efforts (optimization, improvement and scale up)- Manage alternate source projects for Active Pharmaceutical Ingredients (API)- Act as the SPOC for the interface with Global MS & T network and with technical development organization, for the corresponding global activities- Work with Senior Management across all sites and global team to implement standardized procedures for harmonization purposes. Assist other sites with difficult processing related issues- Perform troubleshooting activities for daily support of manufacturing related to process and equipment issues- Evaluate and develop new technologies- Provide off -hour on-call support to manufacturing. Document findings, author reports and regulatory documents that require significant interaction with other functional groups within the site- Work under limited supervision of senior management and understand company goals / objectives and apply them when resolving a variety of problems- Contribute to the completion of specific programs and projects. Frequent inter-organizational and outside customer contacts- Represent the organization in providing solutions to difficult technical issues associated with specific projects- Commercial support as needed- Responsible for all Technology transfer activities from other sites. Member of the MS & T safety team and role is to identify safety issues within our group and provide solutions to mitigate the safety issues.

Skills

• Fda
• Gxp
• Technology Transfer
• Quality System
• Validation
• Manufacturing
• Trackwise
• Qbd
• Change Control
• Design of Experiments
• Regulatory Affairs
• 21 Cfr Part 11
• Quality by Design
• Regulatory Submissions
• Six Sigma, (Green Belt, Lean Sensei, and Black Belt)
• Lims
• Capa
• Sop
• Pharmaceutics
• Pharmaceutical Industry
• Certificate of Completion in Project and Time Management
• Gdp
• Gmp