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Job Description - (170009WE)
Analytical Senior Scientist (M / F)(
Job Number : 170009WE)
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 :
Analytical Senior Scientist (M / F)
Based in the Lausanne region of Switzerland, in an innovative and dynamic environment, you will be report to the Head of Analytical Science and will :
Contribute to design and oversee primarily Small Molecule (Oral and Topical) 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.
Contribute to 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).
Major activities include outsourcing of key activities such as product characterization, method development / optimization / validation / transfer, proposing specification and analytical control strategies, recommending stability programs and packaging safety strategy (i.
e. leachable and extractible).
Responsibilities : 1)- Operations
Contribute to analytical development plan and stability program for Drug Substance and Drug Product in cooperation with external partner and internal experts, in line with business priorities, following a Quality by Design framework (ICH Q8, ICH Q11)
Contribute to / or Support the conception, design, and interpretation of scientific and technical data to support projects decision making
Apply broad and deep analytical knowledge and experience to the analytical development, performance and characterization of drug substances and drug products (e.
g. LC, GC, LC-MS, Rheology, IVRT, Dissolution Test)
Design stability program in close cooperation with Internal Experts (e.g. Pharmaceutical Development Expert, Senior Expert Formulation and Process Development, Head of Chemical Development) and external partners
Apply statistical analysis for interpretation of analytical and stability data, set the shelf life and storage conditions of drug substances and drug products
As a core team member, prepare and present data to internal project team meetings, and recommend sound scientific / technical decisions based on data analysis and experience
Solve complex problems (e.g. deviations, OOS) through collaborations with others
Recommend and technically qualify external partner (e.g. CDMO, CRO) and contribute to strategic partnership (e.g. academic)
Act as key contributor to create and enhance collaborative and trusting relationships with external partners
Ensure close liaison with Operations to prepare, execute and support technical transfer to the late stage of development,
Support Operations by providing scientific and technical expertise to ensure maintenance of in market products
Contribute to set a risk management table, update it as necessary and escalade in a timely manner any critical risk to the Supervisor
Contribute to define and execute mitigation and contingency plan
Plan efficiently activities and ensure strict monitoring of milestones and budget
Act as a voice and ambassador of its department at various governance bodies / meetings
2)- Regulatory Submissions, Documentation and Compliance :
Author, review and / or approve key documents such as : method development reports, validation protocols / reports, and justification of specifications, stability protocols / reports, shelf life and storage conditions statement and relevant sections of regulatory filings (IND, IMPD, NDA etc.)
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 and report in a timely manner any major or critical issue
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
3)- Knowledge Management :
Maintain awareness of cutting-edge and specific technologies in the field of small molecule and ensure knowledge acquisition
Proactively contribute to implement regional regulatory requirements and guidelines that impact analytical sciences in close cooperation with Pharmaceutical Development Expert and other functions
Maintain current awareness of GMP and other regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future operations and products
May attend congresses, conferences and training courses to ensure continuous expertise growth and visibility of Nestlé Skin Health
Contribute to publish / present in high quality journals / conferences in line with the function strategy
4)- 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 strategy for patent submission and / or defense in close cooperation with Industrial Property Team and Head of Functions
Education and Experience Requirements :
PhD+5Y or MS+15Y in Chemistry, Analytical Chemistry, Biotechnology, Pharmaceutical Sciences or closely related to the field
Established track record of success with oral and topical developments
Experience working with external partners (e.g. CDMO, CRO, Academic)
In-depth scientific knowledge and experience in developing and validating analytical methods, covering different technics and methods (e.
g. LC, GC, LC-MS, Rheology, IVRT, Dissolution Test)
Solid understanding of performance, characterization, technology transfer and troubleshooting when it comes to drug substances and drug products (Oral and Topical)
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
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
Desirable experience in biological analytical development
Location : Lausanne Region, Switzerland.
May 7, 2018, 5 : 54 : 43 AM