Regulatory Scientist

Syngenta Group•Durham, NC

3d•Onsite

About The Position

Syngenta's Traits Characterization and Product Safety (TC&PS) group is committed to applying world-class science and winning innovation to offer farmers safe, cost-effective solutions that address the demands of a rapidly changing world. We are looking for a scientist with experience in molecular biology and sequencing to join our Molecular Characterization Team. As a Regulatory Scientist, you will design, execute, and oversee molecular characterization studies, and prepare safety study reports following Good Laboratory Practice Standards (GLPS) to support regulatory submissions of Syngenta's genetically modified (GM) crops and products developed through New Genomic Technologies (NGT), such as gene editing. You will provide technical guidance and scientific advice across broad areas of expertise, and will work with cross-functional teams to support development of GM and NGT crop products and to interpret and apply safety assessments required by regulatory authorities for product approval and maintenance.

Requirements

PhD degree, or equivalent combination of education and experience, with at least 6 years of professional experience in Plant Biology, Molecular Biology, Genomics or related discipline.
Demonstrated proficiency in Next Generations Sequencing (NGS), data handling, pipeline optimization and development, and Bioinformatic analyses, Linux environment, and desired experience in relevant programing languages (e.g. Bash scripting, Python).
Demonstrated proficiency in molecular biology laboratory techniques, encompassing DNA and RNA extraction from plants, cloning, PCR, and sequencing (e.g. Sanger, Illumina, PacBio, Oxford Nanopore), with desired experience in CRISPR-Cas technologies.
Demonstrated proficiency for designing, conducting, interpreting and reporting molecular characterization studies, preferably of GM or NGT crops, using standard methodologies (sequencing, real-time PCR), and proven record of solving difficult and complex technical problems.
Understanding of regulatory science and study requirements for the molecular characterization of GM and NGT products and their safety assessments is desirable.
Candidates must be legally authorized to work in the United States on a permanent basis without requiring current or future sponsorship (which also encompasses OPT/CPT and H-1B visas).

Nice To Haves

Experience as GLP study director or monitor of GLPS or familiarity with quality management systems is preferred.
Experience working with external collaborators and contract research organizations is desirable.

Responsibilities

Independently plan, execute, and coordinate the delivery of studies conducted by the Molecular Characterization Team (MCT) in compliance with all safety, GLPS, and regulatory requirements.
Document experiments and results, interpret data, and write and review complex technical documents (protocols, reports, Standard Operating Procedures, guidance documents).
Provide technical expertise and guidance on the application of molecular biology and sequencing technologies for characterization of GM and NGT products (e.g. sequencing, applications of gene editing technologies such as CRISPR-CATCH, real-time PCR).
Evaluate new and state-of-the-art molecular (DNA, RNA) characterization technologies and establish validated methodologies to enable the expansion of tools available for characterizing various data sets.
Play an active role in identifying, solving, and managing a variety of technical issues or challenges.
Identify risks to Syngenta products and contribute to the development, communication, and implementation of risk management and mitigation plans.
Communicate complex technical issues with stakeholders, provide techno-regulatory expertise, and prepare technical documents as required by regulatory authorities.
Lead projects and/or represent TC&PS in multi-disciplinary regional or global product development teams, providing key input into the development of regulatory and safety strategies.
Stay at the forefront of technological and techno-regulatory advancements to enhance and maintain technical expertise, deliver maximum value for Syngenta, and establish yourself as a trusted subject matter expert.
Play an active role in identifying operational bottlenecks and establishing efficient ways-of-working through process development and optimization.