Overview
Senior Formulation Scientist and Quality Assurance Jobs in Naples, USA at Medical Group Care
Benefits:
- 401(k) matching
- Bonus based on performance
- Health insurance
- Paid time off
About the Role
We are seeking a highly skilled and experienced Senior Formulation & Quality Assurance Scientist to join our growing team. In this dual‑focus role, you will be responsible for developing innovative, safe, and effective formulations across FDA‑regulated categories in cosmetics and health while ensuring that all products meet rigorous quality, regulatory, and safety standards. The ideal candidate brings a deep passion for cosmetic science, a sharp analytical mindset, and a proven track record in both the lab and in quality systems.
Key Responsibilities Ideation, Strategy & Market Opportunity
- Lead white space research and competitive landscape analysis to identify consumer needs and market share growth opportunities across cosmetics, OTC, and medical device categories to grow (own merit) category for both retail and cobtorl brands.
- Benchmark formulations, claims, performance, and cost structures against national brands and category leaders to inform innovation and positioning strategies. Translate consumer insights, clinical needs, and regulatory constraints into clear technical and commercialization roadmaps.
Product Formulation & Technical Ownership
- Own the development and formulation specifications as the subject‑matter‑expert (SME).
- Design, develop, and optimize skincare formulations across Cosmetic skincare and personal care assortments, OTC drug products (e.g. acne, dandruff, skin protectants, sun‑screens, cold/cough remedies, digestive health) and Medical devices and combination products, where applicable.
- Take full ownership of formulations, including composition, processing parameters, stability, performance, and cost optimization.
- Source and evaluate raw materials and active ingredients in collaboration with key stakeholders and maintain clear communication in driving cost‑effective strategies while maintaining competitiveness in market share.
- Guide and partner with contract manufacturers (co‑mans) and their technical teams, providing direction on formulation refinement, process optimization, and scale‑up readiness.
- Lead formulation advancement from bench prototype → pilot → full‑scale commercial production, resolving scale‑related challenges proactively.
- Evaluate, qualify, and approve raw materials, actives, excipients, and packaging components in alignment with regulatory and quality requirements.
- Conduct and interpret stability, compatibility, and efficacy testing to validate new formulations.
- Stay current with emerging ingredients, technologies, and consumer trends to drive product innovation.
- Work cross‑functionally with marketing, packaging, and regulatory teams to bring products from concept to commercialization.
Commercialization & Scale‑Up
- Own technical readiness for launch, ensuring formulations are robust, reproducible, and commercially viable.
- Support roadmap transfer to manufacturing sites, processing instructions and specifications, and critical quality attributes.
- Ensure seamless collaboration across to meet launch timelines.
- Identify and mitigate technical, quality, and regulatory risks prior to commercialization.
Quality Assurance
- Maintain data‑driven quality management systems (QMS) in accordance with GMP, relevant ISO standards and regulatory frameworks.
- Develop and implement streamlined, standardized processes across contract manufacturing partners to improve operational efficiency, reduce cycle times, and ensure consistent, on‑time delivery of development and commercialization milestones.
- Establish and oversee SOPs for raw material testing, in‑process checks, and finished product release.
- Investigate and resolve product quality complaints, non‑conformances, and deviations using root cause analysis (e.g., CAPA, 8D).
- Ensure all products comply with applicable cosmetic regulations (FDA, EU Cosmetics Regulation, or relevant regional standards).
- Maintain and review safety data sheets (SDS), product safety assessments, and documentation for regulatory submissions.
Qualifications Education
Bachelor’s degree (minimum) in Cosmetic Science, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related…
Title: Senior Formulation Scientist and Quality Assurance
Company: Medical Group Care
Location: Naples, USA
Category:
