Division: Product Safety
Function: Product Safety
City: Research Triangle Park
State/Province: North Carolina [NC]
Country: United States [US]
Position Title: Technical Expert 2, 3 or 4 – Molecular Biologist
Job ID: 3737
Role purpose / Accountabilities:
Experienced scientist to provide technical expertise in the area of characterization of genetic material in genetically modified crops in support of global and regional safety and registration activities.
- Design and conduct studies, analyze data, prepare technical positions and develop solutions to technical problems associated with the characterization of genetic material in genetically modified crops. Assure testing procedures meet international standards where applicable.
- Extract and characterize DNA from plant samples using standard molecular techniques (e.g. Southern blot, transcript analysis, sequencing, bioinformatics).
- Write and review protocols, study reports, position papers.
- Advocate study designs, strategies and technical positions to project teams, other internal stakeholders and external stakeholders (e.g. regulators) as needed.
- Monitor study programs at external contract research organizations (includes contracting and work program monitoring) and assure timely delivery.
- Serve as GLP-Study Director accountable for timely delivery of studies conducted internally as part of the comprehensive regulatory data packages in support of the global registration of genetically modified food crops.
- Act as project lead or key participant in designated projects, setting strategy and developing regulatory project plans.
- Share expertise, knowledge and data with internal stakeholders. Opportunities exist to share work externally through scientific publications, meetings with regulators and presentations to external audiences.
- Remain abreast of current research to identify potential opportunities and issues.
Knowledge, Skills & Experience:
- The position demands wide-ranging knowledge of molecular biology and a realistic appreciation of how to solve problems in relation to regulatory questions through data development. A Masters or PhD in Molecular Biology or a related subject is required.
- A minimum of a Master’s degree in molecular biology or a related field plus 5 years of work experience is required for this position. The incumbent must demonstrate expertise within their field, with sustained performance and accomplishments and a proven track record of solving problems.
- Proficient experience in the characterization of genetic material in genetically modified crops. Clear evidence of experience and expertise working with genomic Southern blot analysis is required.
- Experience operating under GLP and to retain high quality standards, is an advantage.
- Experience managing and delivering multiple projects under tight timelines is highly desired
Critical technical, professional and personal capabilities:
- A strong capacity for critical thinking and problem solving.
- Ability to work effectively within a matrix environment and on multidisciplinary teams
- Ability to interpret critical data and statistical analyses from experimental data
- Ability to work to business critical deadlines
- Strong written and verbal communication skills
- Ability to interact and communicate with internal and external stakeholders
Critical leadership capabilities:
- Sets ambitious strategic goals by
o Developing clever strategies and aligning objectives for individuals and teams
o Prioritizing actions and ensuring appropriate support and resource
- Communicates inspirationally by
o Gaining commitment of stakeholders in a compelling way
o Aligning objectives to the company strategy and adding value
- Manages Performance to ensure high standards by
o Skillfully planning, organizing and monitoring performance to meet deadlines
o Sensing and adapting to the changing environment to achieve excellence in delivery; recognizing and Celebrating success, learning from failures
- Develops self and others by
o Coaching others to excel by giving clear, direct and skillful feedback
o Providing opportunities for learning, development and growth
Critical Success Factors & Key Challenges:
- Technical expertise in molecular biology applied to deliver studies necessary to ensure successful global registration of genetically modified food crops.
- Ensure accurate capture of ongoing studies (and associated resource costs) and expected due dates; communicate resource shortcomings to the next level manager.
- Ability to design studies, generate creative solutions to complex technical problems in relation to regulatory requirements and challenges. Success based on ability to support technical positions on the basis of sound science, data and logic.
- Exceptional writing and communication skills, able to prepare and review complex technical documents (reports, protocols, SOPs, regulatory documents), in a clear and easy to understand manner.
- Maintain and improve highest quality standards.
- All applicants must be eligible to work in the US.
- Minimal travel requirements: 5%
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