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Senior Formulation Scientist and Quality Assurance

Medical Group Care

Naples, FL

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JOB DETAILS
SKILLS
Analysis Skills, Benchmarking, Biochemistry, Biology, Biotech and Pharmaceutical, Check Processing, Chemistry, Clinical Practices/Protocols, Code of Federal Regulations, Communication Skills, Competitive Analysis/Strategy, Competitive Research, Consumer Market Share, Continuous Improvement, Contract Manufacturing, Contract Processing, Cost Control, Cross-Functional, Customer/Client Research, Datasheets, Documentation, Drug Products, ERP (Enterprise Resource Planning), Emerging Technology, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Health Insurance, ISO (International Organization for Standardization), Insurance Regulations, Manufacturing, Market Share, Market Trend Analysis, Marketing, Materials Testing, Medical Equipment, Needs Assessment, Operational Improvement, Operational Strategy, Operations Management, Performance Tuning/Optimization, Personal Care, Problem Solving Skills, Process Improvement, Process Manufacturing, Product Safety, Project/Program Management, Prototyping, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Resolve Customer Issues, Retail, Safety Standards, Standard Operating Procedures (SOP), Team Player, Testing, Time Management
LOCATION
Naples, FL
POSTED
15 days ago
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 infomr innovation and positioning strategies.
translate cosnumer 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, suncreens, cold/cough remedies, digestive health) and Medical devices and combination products, where applicable
- take full ownership of formulations, including composition, processing parameters, stabilty, 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 startegy(ies) while maintaining competitive in market share.
- guide and parter with contract manufacturers (co-mans) and their technical teams, providing direction on formulation refinement, process optimization, and scale-up readiness.
- lead formulation advacement from bench prototype >>pilot >> full-scale commercial production, resolving scale-related challenges proactively.
- evaluate, qualify, and approve rwa materials, actives, excipients, and packaging components in alignments 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.


Commercilization & Scale-Up
- own technical readiness for launch, nsuring formulations are robust, reproducible, and commercially viable.
- support road map transfer to manufacturing sites, processing instructions and specifications, and critical quality attributes.
- ensure seamless collaborationacross 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 standardsand regulatory frameworks.
- develop and implement streamlined, standardized processes across contract manufacturing parters 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 field.
Master's degree or PhD is a strong advantage.
Experience
5+ years of hands-on experience in skincare product formulation.
5+ years of experience in a quality assurance or regulatory compliance role within the cosmetics or
personal care industry.
Demonstrated experience working with a wide range of cosmetic raw materials, emulsion systems,
actives, and preservative systems.


Skills & Knowledge
Deep knowledge of cosmetic chemistry, skin biology, and ingredient interactions.
Proficiency with formulation software and laboratory equipment (rheometers, pH meters,
spectrophotometers, etc.).
Strong understanding of global cosmetic regulatory requirements (FDA 21 CFR, EU No. 1223/2009, ISO
22716, etc.).
Experience with stability testing protocols (ICH guidelines or equivalent).
Excellent analytical, problem-solving, and documentation skills.
Strong project management and cross-functional collaboration abilities.
Familiarity with ERP and QMS software is a plus.

Soft Skills & Leadership Competencies
- self-starter with high initiative; thrives in fast-paced, ambiguous environments
- innovative and forward-thinking mindset, with ability to seek forward towards continuous improvement.
- results-oriented problem solver who delivers practical, scalable solutions.
- strong ownership mentality with accountability of outcomes.
- effective communicator capable of influencing without authority.
- able to work independently while collaborating seamlessly across teams. 

About the Company

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Medical Group Care