Senior CMC Expert, Biologics (M/F)

  • Galderma
  • Lausanne, VD, Switzerland
  • 11/09/2019
Full time Data Science Data Analytics Big Data Statistics

Job Description

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 Global SIG Rx organisation, we are currently looking for:Senior CMC Expert, BiologicsBased in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be attached to the Head of Pharmaceutical Development and will:Provide expertise and leadership in the development, communication and implementation of global CMC strategy in support primarily of systemic development programs (i.e. biological products) in accordance with the SIG Rx strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfill patients, health care professional and payers’ needs.Responsabilities:
(1)- CMC Expertise:

  • Contribute to the definition and the implementation of the CMC 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 pharmaceutical 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 (i.e. IND, CTA, BLA)
  • Contribute to Quality by Design CMC development strategy (e.g Quality Target Product Profile).
  • Act as voice and ambassador of the Pharmaceutical Development Department in governance bodies and meetings

(2)- Coordination:

  • Leverage the pharmaceutical expertise to proactively coordinate project cross functional CMC content, in close collaboration with Pharmaceutical Development Functions (i.e. Head of Function and Subject Matter Expert - SME), external partners (i.e. CDMO/CRO/Academic) and Project Management
  • Act as Pharmaceutical Development Representative in the Global Project Team
  • Elaborate with the Heads of Function and SMEs a CMC project 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

(3)- Interactions:

  • 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) and act as NSkinH CMC representative
  • Ensure liaison and coordination between Pharmaceutical Development Department and Operations (i.e. Industrial Development and Plant), notably when transferring a project to the late stage of development
  • Provide support upon request to Operations and CMC Regulatory Affairs to troubleshoot CMC issues and ensure maintenance of commercial products in liaison with Pharmaceutical Development Head of Functions
  • Support external partner oversight and management of CMC Expertise
  • Develop and nurture a network of CMC experts to support SIG Rx strategy

(4)- Knowledge Management :

  • 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
  • Communicate this within the Team and to other staff, as appropriate, and provide key strategic pharmaceutical development expertise inputs to projects and cross-functional teams
  • Identify and attend congresses, conferences and training courses to ensure continuous expertise growth and visibility of Nestlé Skin Health
  • May publish/present in high quality journals/conferences
  • Lead working groups to develop internal policy or guideline

(5)- Other activities:

  • Contribute to the innovation and continuous improvement process by proposing solutions in line with the strategy of the SIG Rx
  • 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 expertise supporting worldwide product development in the related field
  • Demonstrated understanding of CMC 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
  • 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
  • Demonstrated ability to set CMC strategy and to interact with competent authorities
  • Effective leadership, project management, interpersonal skills
  • Excellent verbal and written communication (English)
  • Ability to lead and promote changes
  • Ability to solve complex problems and to propose innovative solutions
  • Demonstrated knowledge of cGMP requirements
  • The following experiences are considered as a plus: medical device development (e.g. injection device), statistical analysis, small molecule development programs