Regulatory Scientist (Technical Expert 3)
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Job Location:
Durham, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Syngentas 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 (Technical Expert 3) 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 Syngentas 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.
Accountabilities:
- 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.
Qualifications :
PLEASE NOTE: Candidates must be legally authorized to work in the United States on a permanent basis without requiring current or future sponsorship (which also entcompasses OPT/CPT and H-1B visas).
- 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.
- 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.
Additional Information :
What We Offer:
- A culture that celebrates belonging and collaboration promotes professional development and strives for a work-life balance that supports the team members. Offers flexible work options to support your work and personal needs.
- Full Benefit Package (Medical Dental & Vision) that starts your first day.
- 401k plan with company match Profit Sharing & Retirement Savings Contribution.
- Paid Vacation Paid Holidays Maternity and Paternity Leave Education Assistance Wellness Programs Corporate Discounts among other benefits.
Syngenta has been ranked as a top employer by Science Journal. Learn more about our team and our mission here: is an Equal Opportunity Employer and does not discriminate in recruitment hiring training promotion or any other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status.
WL: 4B
#LI-Onsite
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
To help feed 10 billion people while reducing emissions and improve biodiversity. This is our mission as the global agriculture technology leader. With 59,000 employees in more than 100 countries and hundreds of thousands of agricultural partners worldwide, we are committed to transfo ... View more
