Scientist, Scientific Affairs - Guaynabo, Puerto Rico

Unicity USA•Las Vegas, NV

4d•Hybrid

About The Position

The Scientist, Scientific Affairs, will be a resident expert on health and nutrition matters including providing guidance on the technical validity of claims, technical assessment of bioactive ingredients, and coordination of research programs internally and with external partners, including design and execution of fit-for-purpose clinical studies. Unicity is dedicated to developing innovative, science-based products and programs that promote metabolic health and improve the quality of life for people everywhere. For over 30 years, Unicity has been dedicated to developing high-quality products that contain the vital nutrients your body needs. With the proper process, cutting-edge technology, and a mission to Make Life Better, Unicity is paving the way for a better tomorrow.

Requirements

Master’s of Science (M.S.) or Doctor of Philosophy (Ph.D.) degree or higher in a technical field (nutrition, biochemistry, chemistry, exercise and sports science, food science, biology, etc.)
Masters with 3+ years, or Ph.D. with 1+ years of clinical research experience
Ability to search, understand, and apply the scientific literature in developing science-based products to maintain and improve human health
Extensive knowledge of human health and current trends in the nutraceutical industry
Good interpersonal, analytical, and organizational skills
Must have strong oral and written communication skills including the ability to explain science to non-scientific audiences
Understand GCP, ICH E6, and HIPAA requirements
Working knowledge of dietary supplement regulations (DSHEA) and FTC and FDA standards for claims substantiation
Ability to develop study protocols and procedures required in all aspects of conducting scientifically valid internal and external studies
Working knowledge of statistics

Nice To Haves

experience in dietary supplements, functional foods, pharma, or a CRO
IRB submissions
peer-reviewed publications

Responsibilities

Serve as the scientific subject matter expert for internal teams on functional benefits, ingredients, formulations, and product positioning, including risk assessments.
Assess the current portfolio and recommend improvements in ingredients and functional benefits, and develop new product and ingredient claims and health and nutrition propositions.
Track emerging health trends and new research, and share insights and future opportunities with leadership.
Validate the safety, efficacy, and regulatory status (e.g., GRAS, NDI) of botanical and bioactive ingredients.
Design fit-for-purpose studies: match the research question, endpoints, population, and study size to the claim, the timeline, and the budget.
Independently lead internal studies, real-world evidence and consumer studies, and decentralized clinical research. This includes writing protocols, informed consent forms, and IRB submissions, and overseeing study conduct, data quality, and analysis.
Coordinate external scientific and clinical testing, and build relationships with key opinion leaders and clinical research organizations.
Develop and substantiate claims to FTC and FDA standards, support claims review for international markets (e.g., EFSA, Health Canada), and build substantiation procedures and documents with R&D, Regulatory, and Legal.
Translate science into accurate, compliant content and training for marketing, sales, and distributors.
Review and approve marketing content and advertising for technical accuracy, and present at company events.
Prepare reports, white papers, and publications that accurately represent internal and clinical study results.