Strain Risk Assessment Specialist
2 weken geleden
International Flavors and Fragrances (IFF) is a leader in the industrial biotechnology sector, developing innovative products to advance sustainable solutions. The regulatory function facilitates market access of enzyme products, with product safety assessments playing a crucial part. In this position, you will develop and maintain up-to-date microbial strain documentation in support of strain risk assessment for manufacturing and regulatory approval dossiers for our Health & Biosciences division.
The scope of this position includes collecting information and data essential for safety and regulatory documentation on IFF's microorganisms. Sources include culture collections, published peer-reviewed literature, and governmental and regulatory publications, as well as internal IFF laboratory data. Your main interactions will be with R&D and regulatory affairs, spanning multiple languages, cultures, and time zones.
You will be part of the team responsible for writing and organizing regulatory strain safety documentation. The data on which the assessment is based comes mainly from IFF R&D. This position requires strong laboratory knowledge and experience to interpret data and identify whether additional analyses may be necessary.
Key Responsibilities
- Monitor literature on strain safety relevant topics.
- Monitor biosafety guidelines and regulations applicable to IFF's microorganisms.
- Organize and maintain strain safety documentation.
- Conduct strain risk assessments according to business needs within allotted timeframes.
- Conduct sequence-based analyses relevant for strain safety documentation (such as food allergenicity, toxin homology, open reading frame analyses).
- Support production strain-related compliance matters and biosafety information needed within the strain risk assessment team.
Requirements
- MSc in life sciences, preferably in molecular biology or microbiology.
- Strong attention to detail.
- Team player mindset.
- Demonstrated ability to write scientific papers (peer-reviewed publications) in English.
- Excellent written and verbal communication in English.
- ~5 years of experience in Regulatory or R&D, with a focus on microbial strain development/documentation.
- Competency in computer/software tools, including sequence software, Microsoft Office, and SharePoint, etc.
- Affinity with sequencing data.
- Ability to thrive in a multidisciplinary and multicultural global matrix environment.
- Strong analytical mind with the ability to interpret laboratory study results and see connections.
- Willingness to keep learning and developing IFF's strain risk assessment processes.
Preferred Qualifications
- PhD degree in Biosciences: e.g., molecular biology, microbiology.
- Excellent planning, timekeeping, and organizational skills.
- Affinity with document editing and organization.
- Understanding of risk assessment methodology and ability to interpret study results.
- Experience working in a multidisciplinary global corporate environment.
Location
Preferably Oegstgeest, the Netherlands (NL). Open to other locations (such as Wilmington, DE or Palo Alto, CA).
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