R&D Pharmaceutical Formulation Scientist
Meds, Elmhurst, IL, United States
What You'll Do
Formulation Development: Lead the end-to-end development of new products, focusing on active ingredient compatibility, texture, and flavor masking.
Portfolio Support: Optimize and scale existing formulations to improve stability and patient experience.
Bench-to-Pilot Scaling: Develop compounding protocols and manufacturing processes that can transition seamlessly from the R&D lab to large-scale pharmacy production.
Regulatory Compliance: Ensure all formulations meet USP 795 (non-sterile compounding) and USP 797 standards, and maintain meticulous documentation for quality assurance.
Analytical Testing: Conduct and oversee stability testing, dissolution studies, and ingredient assays to ensure product integrity.
Project Ownership: Take ownership of projects from concept through pilot scale, ensuring smooth transfer to production and clear communication with cross-functional teams.
Data-Driven Decision Making: Utilize analytical tools (e.g., HPLC, dissolution testing) to generate meaningful insights that guide formulation decisions and scale-up readiness.
Formulary Innovation: Work across multiple oral dosage forms—chewables, gummies, and ODTs—to improve taste, texture, and patient experience.
Problem Solving: Apply practical, hands-on problem solving to overcome formulation challenges using data and experimentation rather than theoretical approaches.
Vendor Collaboration: Partner with raw material suppliers to source high-quality APIs and excipients, staying ahead of industry trends in pharmaceutical compounding.
Compliance Oversight: Ensure all formulations comply with regulatory standards and guidelines and understand 21 CFR FDA drug compliance requirements.
Quality Control & Assurance: Ensure internal quality standards are met and implement and maintain quality control processes throughout development.
Stakeholder Communication: Work collaboratively with cross-functional teams, including quality control, regulatory affairs, and production, and communicate project status, challenges, and results effectively.
Project Management: Manage multiple projects simultaneously, ensuring timelines and budgets are met, identify potential risks and develop mitigation strategies, and prepare project reports and presentations for internal and external stakeholders.
Continuous Learning: Stay updated with the latest advancements in pharmaceutical formulation and regulatory requirements.
Qualifications
Education: BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
Experience: 3–6 years of experience in pharmaceutical formulation or compounding (R&D setting preferred).
Chewable Expertise: Specific experience with chewable tablets, gummies, or oral disintegrating tablets (ODTs) is a major plus.
Technical Knowledge: Deep understanding of excipient functionality, flavor chemistry, and the physical chemistry of solid dosage forms.
Regulatory Familiarity: Knowledge of FDA regulations and USP compounding standards.
Startup Mindset: Comfortable working in a fast‑paced environment where priorities can shift and enjoys the “build” phase of a product.
Work Environment
Laboratory and office settings.
May require handling of hazardous materials and adherence to safety protocols.
Collaboration with team members and departments to achieve project goals.
We are looking for top talent that wants to make a measurable impact in an exciting, fast‑paced environment in our Elmhurst, IL Lab (fully onsite).
#J-18808-Ljbffr
Formulation Development: Lead the end-to-end development of new products, focusing on active ingredient compatibility, texture, and flavor masking.
Portfolio Support: Optimize and scale existing formulations to improve stability and patient experience.
Bench-to-Pilot Scaling: Develop compounding protocols and manufacturing processes that can transition seamlessly from the R&D lab to large-scale pharmacy production.
Regulatory Compliance: Ensure all formulations meet USP 795 (non-sterile compounding) and USP 797 standards, and maintain meticulous documentation for quality assurance.
Analytical Testing: Conduct and oversee stability testing, dissolution studies, and ingredient assays to ensure product integrity.
Project Ownership: Take ownership of projects from concept through pilot scale, ensuring smooth transfer to production and clear communication with cross-functional teams.
Data-Driven Decision Making: Utilize analytical tools (e.g., HPLC, dissolution testing) to generate meaningful insights that guide formulation decisions and scale-up readiness.
Formulary Innovation: Work across multiple oral dosage forms—chewables, gummies, and ODTs—to improve taste, texture, and patient experience.
Problem Solving: Apply practical, hands-on problem solving to overcome formulation challenges using data and experimentation rather than theoretical approaches.
Vendor Collaboration: Partner with raw material suppliers to source high-quality APIs and excipients, staying ahead of industry trends in pharmaceutical compounding.
Compliance Oversight: Ensure all formulations comply with regulatory standards and guidelines and understand 21 CFR FDA drug compliance requirements.
Quality Control & Assurance: Ensure internal quality standards are met and implement and maintain quality control processes throughout development.
Stakeholder Communication: Work collaboratively with cross-functional teams, including quality control, regulatory affairs, and production, and communicate project status, challenges, and results effectively.
Project Management: Manage multiple projects simultaneously, ensuring timelines and budgets are met, identify potential risks and develop mitigation strategies, and prepare project reports and presentations for internal and external stakeholders.
Continuous Learning: Stay updated with the latest advancements in pharmaceutical formulation and regulatory requirements.
Qualifications
Education: BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
Experience: 3–6 years of experience in pharmaceutical formulation or compounding (R&D setting preferred).
Chewable Expertise: Specific experience with chewable tablets, gummies, or oral disintegrating tablets (ODTs) is a major plus.
Technical Knowledge: Deep understanding of excipient functionality, flavor chemistry, and the physical chemistry of solid dosage forms.
Regulatory Familiarity: Knowledge of FDA regulations and USP compounding standards.
Startup Mindset: Comfortable working in a fast‑paced environment where priorities can shift and enjoys the “build” phase of a product.
Work Environment
Laboratory and office settings.
May require handling of hazardous materials and adherence to safety protocols.
Collaboration with team members and departments to achieve project goals.
We are looking for top talent that wants to make a measurable impact in an exciting, fast‑paced environment in our Elmhurst, IL Lab (fully onsite).
#J-18808-Ljbffr