Head of Chemical Development (EN)
Nestlé
Lausanne,VD,Switzerland
vor 3 Tg.

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 organization, we are currently looking for :

Head of Chemical Development (M / F)

Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will report to the Head of Pharmaceutical Development :

Lead, design and oversee drug substance development in accordance with the SIG Rx strategy, any applicable regulatory requirements and / or local rules and industrial requirements, to fulfill patients, health care professionals and payers’ needs.

Lead, design and oversee scientific studies in support of technical programs as they progress from early development into confirmatory development, technology transfer up to the registration and to support as needed manufacturing process at the commercial site (e.

g. troubleshooting, maintenance).

1)- Chemical Development :

  • Contribute to the definition and the implementation of the Pharmaceutical Development strategy in line with the overall SIG Rx strategy
  • Propose the Chemical Development strategy in line with the overall SIG Rx strategy, identify and implement the necessary actions and solutions
  • Provide expertise (i.e. act as a Subject Matter Expert) and leadership in the development, communication and implementation of the small molecules (systemic and topical) chemical development strategy in support of product portfolio execution
  • Contribute to chemical development activities at early stages (i.e. from B decision to preclinical batches) and operate in close cooperation with Research
  • Lead and organize chemical development late stages (i.e. from first GMP clinical batches to commercial phases)
  • Elaborate chemical development strategy in line with Quality by Design guideline
  • Identify, select and maintain a pool of CDMOs (Contract Development Manufacturer Organization) in close cooperation with Research, Procurement and Quality Management
  • Oversee Drug Substance CDMO activities and ensure implementation of the plans
  • Ensure technical and quality oversight of the Drug Substance CDMO, review manufacturing process changes and assess change controls for impact that can affect both process performance and product quality
  • Assess all major deviations and any out of specifications results that impact drug substance quality and release
  • Take into account current and evolving requirements and guidelines to ensure that the content of Drug Substance work packages and documentation are phase appropriate
  • Support documentation preparation for regulatory purpose
  • Act as voice and ambassador of the Chemical Development function in governance bodies and meetings
  • 2)- Coordination :

  • Interacts closely with the Pharmaceutical Development Expert to support CMC drug substance development strategy and ensure consistency throughout the development
  • Contribute to the project pharmaceutical development plan including milestones, external costs and internal resources needs
  • Ensure projects meet agreed timelines and budget (external costs)
  • Contribute to set a risk management table, update it as necessary
  • Contribute to define mitigation and contingency plans
  • Ensure monthly reporting of the chemical development activities
  • 3)- Interactions :

  • Works closely with the Analytical Sciences function, review analytical methods, validation protocol and reports, contribute to the stability program, analysis and interpretation of the results and ultimately contribute to the control strategy
  • Support Analytical Sciences as Chemistry SME when dealing with impurities management and structural analysis or degradation pathway identification
  • Work closely with Formulation and Process Development Expert (e.g. to set pre formulation strategy)
  • Ensure liaison with Operations (i.e. Industrial Development and Supply Chain) as necessary
  • Provide support upon request to Operations and CMC Regulatory Affairs to troubleshoot CMC issues and ensure maintenance of commercial products
  • 4)- Knowledge Management :

  • Monitor, assess and proactively contribute to implement guidelines and / or scientific and technology trends (i.e. new technologies) that impact chemical development activities
  • Ensure communication and training within the Organization
  • Lead working groups to develop internal policy, guideline or operating model
  • Identify and attend congresses and forum to ensure continuous expertise growth and visibility of Nestlé Skin Health
  • Publish / present in high quality journals / conferences
  • 5)- Compliance :

  • Author standard operating procedures and working instructions required by the activities
  • Ensure close oversight of GMP activities that are conducted externally to ensure at each stage of development an appropriate level of quality requirements
  • Ensure that external partners operate in compliance with Safety, Health and Environment Nestlé policy
  • Actively contribute to the preparation of audits and inspections, internally or at external partner’ site
  • 6)- 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 proposal / review / defense as needed and ensure consistency with regulatory dossiers
  • Contribute to the budget preparation of the Department
  • Education and Experience Requirements

  • PhD in Chemistry, MS in Chemistry, Chemical Engineering or closely related to the field and at least 10+ years of relevant experience
  • Established track record of success with drug substance development including botanical drug substance
  • Experience working with external partners (e.g. CDMO, CRO, Academic)
  • Sound technical qualifications and deep knowledge in developing and transferring drug substance manufacturing process
  • Laboratory experience in the field
  • Solid understanding of process engineering and characterization of the drug substance
  • Excellent understanding of cGMP, Pharmacopeia, ICH guidance and applicable guidelines
  • Experience in authoring analytical-related CMC sections of IND / IMPD and NDA / CTD regulatory submissions
  • Practical experience in implementing the principles of Quality by Design
  • Knowledgeable in statistical analysis and design of experiment
  • Excellent communication, negotiation and external follow-up
  • Excellent verbal and written communication skills (English) and the ability to work in a team environment with cross-functional interactions
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