Nestlé Skin Health is a global leader in improving the quality of life by delivering innovative medical solutions for the health of skin, hair and nails throughout people's lives. Nestle Skin Health aims to meet the needs of healthcare professionals and consumers through constant innovation in technology and products to protect and improve the health of the skin and treat skin diseases. Nestlé Skin Health is a subsidiary of Nestlé.
For our Galderma, Global SIG Rx organization, we are currently looking for:
CMC Development Expert, NBE (M/F)
Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will report to the Head of CMC Development.
The CMC Development Expert, NBE, in accordance with CMC Development and SIG Rx will leverage cross functional scientific/technical understanding of biologics development and sound knowledge of global regulatory guidelines to proactively drive and coordinate projects’ cross functional CMC content, in close collaboration with individual CMC Development functions/experts, external partners and Project Management.
Responsibilities
• Contribute to the definition and the implementation of the CMC Development strategy in line with the overall SIG Rx strategy
• Provide expertise and leadership in the development, communication and implementation of global CMC strategy in support of product portfolio execution
• Take into account current and evolving requirements and guidelines to ensure that the content of CMC work packages and documentation are phase appropriate
• Ensure a balanced approach to CM development risk, understanding the impact to the business and enabling smooth approval of regulatory submissions
• Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
• Review and approve CMC and quality documents as needed (i.e. IND, CTA, BLA)
• Contribute to Quality by Design pharmaceutical development strategy (e.g Quality Target Product Profile).
• Coordinate project cross functional CMC content, in close collaboration with CMC Development Functions (i.e. Head of Function and Subject Matter Expert - SME), external partners (i.e. CDMO/CRO/Academic) and Project Management
• Act as CMC Development Representative in the Global Project Team
• Elaborate with the Heads of Function and SMEs a project CMC development plan including milestones, external costs and internal resources needs
• Elaborate with the Heads of Function and SMEs a risk management table, update it as necessary and escalade in a timely manner any critical risk
• Develop with the Heads of Function and SMEs mitigation and contingency plans
• Ensure monthly reporting of the assigned projects portfolio
• Work closely with CMC Regulatory Affairs and ensure alignment regarding questions and strategies, driving development of science based argumentation to obtain buy-in of regulatory agencies, together with appropriate Heads of Function and SMEs
• Attend CMC meetings with Health Authorities (e.g. FDA, PMDA, EMA) as needed
• Monitor, assess and proactively contribute to implement regional regulatory requirements and guidelines that impact pharmaceutical development activities
• Maintain current awareness of regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future Rx Development
• Lead working groups to develop internal policy or guideline
• Contribute on purpose to due diligence, scientific assessment of external opportunities and divesting projects
• Support patent review/defense as needed and ensure consistency with regulatory dossiers
• Contribute to the budget preparation of the Department
Education and Experience Requirements
• Pharmacist, PhD, MS in biological sciences, biochemical engineering, or a related discipline, concentration in microbiology, biochemistry might be a plus
• 15Y+ pharmaceutical industry experience, with a minimum of 10Y working in CMC Department supporting worldwide product development in the related field with a significant experience in CMC project management
• Demonstrated understanding of pharmaceutical development in the field of biologics (e.g. cell culture, upstream and downstream process, analytical sciences including characterization and comparability studies, combination product, technology transfer), including Quality by Design methodology
• Experience in combination products and medical device development (e.g. auto injector, prefilled syringe)
• Demonstrated experience in developing and implementing CMC work plans to support phase appropriate activities, including management of timelines and budget
• In-depth knowledge in developing and implementing risk management
• Strong experience in authoring/reviewing regulatory documents (e.g. IND/IMPD, BLA) and in supporting registration process
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported data
• Effective leadership, project management, interpersonal skills
• Excellent verbal and written communication (English)
• Ability to solve complex problems and to propose innovative solutions
• Demonstrated knowledge of cGMP, ISO13485, 21CFR820 requirements