Strain Risk Assessment Specialist
2 weken geleden
Job Description
International Flavors and Fragrances (IFF) is a leader in the industrial biotechnology sector, developing innovative enzyme products for the bio-based economy. The regulatory function facilitates market access of these products, with product safety assessments playing a crucial role. In this position, you will develop and maintain up-to-date microbial strain documentation in support of strain risk assessments 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.
Primary 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.
- Support production strain-related compliance matters and biosafety information within the strain risk assessment team.
Job Requirements
Required Background and Skills:
- 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.
- 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 Background and Skills:
- PhD degree in Biosciences: e.g., molecular biology, microbiology.
- Excellent planning, timekeeping, and organizational skills.
- Affinity with document organization.
- Understanding of risk assessment methodology and ability to interpret study results.
- Experience working in a multidisciplinary global corporate environment.
Job Location: Preferably Oegstgeest, the Netherlands (NL). Open to other locations (such as Wilmington, DE or Palo Alto, CA).
IFF is an Equal Opportunity Employer.
At IFF, we believe that your uniqueness unleashes our potential. We value the diverse mosaic of ethnicity, national origin, race, age, sex, or veteran status. We strive for an inclusive workplace that allows each of our colleagues to bring their authentic self to work, regardless of their religion, gender identity & expression, sexual orientation, or disability.
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