Key Responsibilities:
Cover all aspects of manufacturing and packaging activities required for production of clinical products for all phases and commercial products
Liaison with CMOs
Optimize resources to meet the production plans in the manufacturing unit operations at the CMO’s sites as well as manage the process optimization of laboratory scale formulation and scale-up of the pre-commercial and commercial products
Manage the design and implementation of changes to improve the quality, costs and efficiencies of the process, equipment and methods of manufacturing
Plan and manage the technical transfer including protocols, design, monitoring, science, data management, statistics (KPIs) and reporting
Develop control of robust processes, review existing processes and equipment and configuring manufacturing systems to develop best practices
Performance Process Qualification (PPQ) includes supervise CMOs operations, participate in pre-validation and validation related activities, prepare and/or review protocols and process reports
Manage the Continuous Process Verification (CPV) process for commercial products in accordance with cGMP requirements
Provide technical assistance to manufacturing and quality operations for process troubleshooting as well working with QA to resolve production issues
Plan and execute post approval manufacturing changes
Requirements:
15+ years of process development and/or manufacturing experience focusing in oral solid dosages production. Lyophilization expertise will be an advantage
Experience with technical transfer from lab scale to GMP manufacturing and scaling up to large scale batches (commercial batches)
Experience with Process Validation methodologies including regulations, guidelines, setting strategy for validation and writing of protocol & reports
Familiar with analytical methods development and QC methods
Team player with the ability to work collaboratively with CMOs and other functional area staff
Efficient organizational skills, including the ability to manage multiple tasks and priorities effectively
Full knowledge of planning and monitoring tools (Gant chart for example)
Working knowledge and understanding of the cGMP requirements
Self-learning skills
English at mother tongue level – excellent interpersonal, verbal and written communication skills in English
Education:
B.Sc in Biotechnology/ Chemical/ Material/ Mechanical Engineering or similar, MBA preferred
