Senior Analytical Scientist(

Job Number:

 190002AA)

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, based in La-Tour-de-Peilz/VD, Switzerland, we are currently looking for:

Senior Analytical Scientist

Your mission is to contribute to design and oversee Small Molecule (Oral and Topical) analytical development plan and stability programs in accordance with the SIG Rx strategy, any applicable regulatory requirements and/or local rules and industrial requirements, to fulfil patients, health care professionals and payer needs. You further 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).

 

 

Activities and responsibilities:

• Outsourcing of key activities such as drug substance characterization, method development/optimization/validation/transfer, proposing specification and analytical control strategies, recommending stability programs.


• Contribute to analytical development plan and stability program for primarily Drug Substance and possibly 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)


• Apply broad and deep analytical knowledge and experience to the analytical development and characterization of drug substances and powder (e.g microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques)


• Design stability program in close cooperation with Internal Experts (e.g. CMC Development Expert, Head of Formulation and Process Development, Head of Chemical Development) and external partners


• 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


• Support Operations by providing scientific and technical expertise to ensure maintenance of in market products


• Plan efficiently activities and ensure strict monitoring of milestones and budget


• 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 (DMF, IND, IMPD, NDA etc.)


• 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


• 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 affect analytical sciences in close cooperation with CMC Development Expert and other functions

Your profile:

• PhD+5Y working experience or MS+15Y working experience in Chemistry, Analytical Chemistry, 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. microscopy (SEM, TEM, SEM-EDX, ATR-FTIR), spectroscopy (FTIR, Raman, confocal RAMAN, UV-vis), laser scattering and solid-state characterization techniques (XRPD, DSC, TGA, ITC), powder rheology, surface area determination by BET, particle size and particle shape and morphology techniques
  Solid understanding of characterization, technology transfer and troubleshooting when it comes to drug substances (Oral and Topical)


• Excellent understanding of cGMP, Pharmacopeia, ICH guidance and applicable guideline


• Excellent communication, negotiation and external follow-up skills


• Fluency in Egnlish, both spoken and written, any other language an asset
  Experience and proven ability to work in a team environment with cross-functional interactions

 

  

Primary Location

: Switzerland-VD-La Tour-de-Peilz

Job

: Research/Development

Organization

: Galderma

Schedule

: Full-time

Job Posting

: Nov 7, 2019, 12:05:48 PM