Summary:

Goldbelt C6 is seeking a Subject Matter Expert III (SME) to obtain the specific expertise in protein chemistry to assist in completing scientific reviews and evaluations of infant formula notification submissions, provide consultation to staff on new requirements under the Infant Formula Final Rule and work with staff in providing guidance to industry with regards to the accurate performance of the PER under the new regulation, and other related work.

Essential Job Functions:

• Provide consultive services to staff on the new Protein Efficiency Ratio (PER) requirements and other chemistry-specific areas of an infant formula notification.
• Work closely with the Project Officer throughout this project.
• Work closely with the Infant Formula/Medical Foods staff on analytical methods and protein quality issues. 
• Work closely with the Infant Formula/Medical Foods staff on the evaluation of infant formula notification requests for additional data and information regarding protein efficiency assays and bioassays for determination of protein quality in complex infant formula matrices. 
• Work closely with the Infant Formula/Medical Foods staff to develop draft guidance for conduct and evaluation of protein efficiency ratio and growth monitoring studies in infant formula submissions.
• Work closely with the Infant Formula/Medical Foods Staff in responding to or meeting with industry with regards to the accurate performance of the Protein Efficiency rations (PER) requirements under the new Infant Formula Regulation.
• Contribute to the development of research projects, including new methods, aligned with the CFSAN Nutrition Strategic Plan.
• Provide guidance to staff, as needed, on preparation of Research Scientist Peer Review packages for promotion.
• Work with staff on the preparation of single and multi-laboratory validation protocols, and review and evaluation of data from method development projects, and single and multi-laboratory validation studies.

Necessary Skills and Knowledge:

• Requires subject matter expertise in analytical methods for nutrients and bioactive constituents in foods and dietary supplements, food fortification and technical assessment of nutrient data submitted in infant formula notification or in response to FDA’s notice-and-comment rulemaking on food labeling, infant formula and medical foods.
• Strong command of Microsoft Office Applications (i.e., Word, PowerPoint, Excel, and Outlook)
• Must be able to work under pressure of deadlines.
• Must be trustworthy & honest.
• Must be able to communicate both written & orally in English.

Minimum Qualifications:

• Must have a doctorate in Chemistry or Biochemistry.
• Minimum twenty (20) years of experience in addressing issues of public health.
• At least ten (10) years of work in the area of analytical methods development and assessment for nutrients and bioactive substances in foods and dietary supplements.

The salary for this position is up to $95,000.00 annually. 

Pay and Benefits

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.