Ines Hassen

• Lead a cross-functional CMC expert team—including Regulatory CMC, Quality, Supply Chain, Drug Substance/Drug Product experts, Manufacturing Sites, and Analytical Specialists—to define and implement lifecycle management (LCM) CMC strategies that align with supply chain objectives, business franchise goals, and the overall company strategy for the oncology portfolio, ensuring a patient-centric approach.
• Champion Belonging and Inclusion by establishing an Employee Resource Group dedicated to foster and promote workplace inclusivity for individuals with diverse abilities.
• Manage relationships with external strategic partners to enhance collaboration and drive project success.
• Mentor team members to support talent development and facilitate career growth.
• Ensure compliance with regulatory standards while aligning with industry best practices.
• Cultivate a culture of continuous improvement by promoting open communication psychological safety and empowering employees to contribute their ideas.
• Proactively identify potential risks and implement effective mitigation strategies to minimize impacts on projects and business operations.

• Support complex investigation, new product introduction.
• Standardization of working tools.
• Facilitate problem solving tools.
• Drive deep dive product to evaluate process performance, appropriate control strategy and process improvements.
• Template module 3 .2 P. 3 sections
• Member of continuous improvements

Technical Product Lead – Biotech Product

• Acted as the end-to-end manufacturing process representative within the CMC team.
• Led manufacturing investigations, process validation, and process transfer.
• Monitored and ensured CMO manufacturing performance through continuous process verification (CPV).
• Authored regulatory CMC documentation (Module3).
• Managed projects involving cross-functional and multidisciplinary teams to achieve strategic objectives.

Leadership

• Completed the Director Development Program, a 12-month leadership program for talent focused on Leading People and Insights, Business Acumen and Strategy, Project Management, and Leading Change, delivered by the Center for Creative Leadership.
• Leading within a Matrix workshop within the CMC team to enhance decision-making processes.

Business Processes

• Co-led the development of a global company Technology Transfer business process to standardize practices across the organization.
• Served as a member of the Continuous Improvement Steering Committee

• Technical expertise across multiple manufacturing technologies including oral solid dosage forms (direct compression, coating, capsule)
• Project management of cross functional and multidisciplinary team
• Lead manufacturing investigations, process validation and process transfer
• Ensure CMO manufacturing performance (CPV) and process improvements
• Author CMC document for regulatory (Module 3, FDA type C meeting)

• End to end Pharmaceutical development of generic sterile drug products from Active Pharmaceutical Ingredient (API) sourcing to marketing authorization approval.
• Led external development programs, including process development, technical transfers (both process and analytical), and manufacturing process validation, while authoring development reports and ensuring compliance with Module 3 and Module 2.3 (DCP, CP of NDA).
• Managed CRO and CMO sourcing, conducting due diligence and establishing technical agreements to support project objectives.
• Directed project management activities, including the development of project plans, timelines, execution strategies, and budget negotiations/tracking.
• Acted as a technical expert for innovative global projects, addressing regulatory deficiency letters and troubleshooting process-related issues.
• Contributed to business development efforts by participating in due diligence activities and providing critical technical assessments and insights.

• Technical support for Life Cycle management products: trouble shooting and process optimization (wet granulation, film coating for sustained release form).
• Scale up, process transfer, process optimization and validation

• Formulation-process development- Scale up- process validation- analytical transfer-stability studies
• Pharmaceutical forms and technologies: tablets, direct compression, wet granulation, sachet, effervescent tablets

• Management of the team
• Setting up of a new manufacturing area for high potent drug product (containment)
• Pre-approval inspection for FDA agreement
• Equipment Qualification of new manufacturing area
• Manufacturing process transfer and validation: wet granulation, fluid bed dryer, direct compression

• Management of the development team
• Formulation of low dosage forms (hormones) and high potent drug products, process validation.
• Management of the packaging activity for clinical studies

• Development of capsule, syrup, tablets for clinical phase
• Cleaning validation

• HPLC method Optimization and ICH validation