BlueChew is looking for a hands-on R&D Formulation Scientist to drive the next generation of products. Based out of our state-of-the-art laboratory located within our company-owned pharmacy in Elmhurst, IL, you will be the bridge between initial concept and commercial scalability.
You won't just be tweaking existing formulas; you will be experimenting with novel delivery systems, improving taste profiles, and ensuring the stability and efficacy of medications that reach hundreds of thousands of users.
Join our team in Elmhurst, IL - we're looking for someone who truly values and enjoys working in the lab, not just tolerates it.
What You'll Do- Formulation Development: Lead the end-to-end development of new products, focusing on active ingredient compatibility, texture, and flavor masking.
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- Portfolio Support: Optimize and scale existing formulations to improve stability and patient experience.
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- Bench-to-Pilot Scaling: Develop compounding protocols and manufacturing processes that can transition seamlessly from the R&D lab to large-scale pharmacy production.
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- Regulatory Compliance: Ensure all formulations meet USP (non-sterile compounding) and USP standards where applicable, maintaining meticulous documentation for quality assurance.
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- Analytical Testing: Conduct and oversee stability testing, dissolution studies, and ingredient assays to ensure product integrity.
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- Take ownership of projects from concept through pilot scale, ensuring smooth transfer to production and clear communication with cross-functional teams
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- Utilize analytical tools (e.g. HPLC, dissolution testing) to generate meaningful insights that guide formulation decisions and scale-up readiness
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- Work across multiple oral dosage forms - including chewables, gummies and ODT's to improve taste, texture and patient experience
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- Apply practical, hands-on problem solving to overcome formulation challenges, using data and experimentation rather than theoretical approaches
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- Vendor Collaboration: Partner with raw material suppliers to source high-quality APIs and excipients, staying ahead of industry trends in pharmaceutical compounding.
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Regulatory Compliance:
- Ensure all formulations comply with regulatory standards and guidelines.
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- Understand 21 CFR FDA drug compliance requirements
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Testing and Analysis:
- Perform HPLC stability testing, dissolution testing, and other necessary tests to ensure the efficacy and safety of formulations.
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- Create prototypes and samples for further testing and evaluation.
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- Analyze data and interpret results to guide formulation development.
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- Document all experiments and results accurately and comprehensively.
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Quality Control and Assurance:
- Ensure all formulations meet internal quality standards.
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- Implement and maintain quality control processes throughout the formulation development phase.
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Collaboration and Communication:
- Work collaboratively with cross-functional teams, including quality control, regulatory affairs, and production.
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- Communicate project status, challenges, and results to stakeholders effectively.
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- Stay updated with the latest advancements in pharmaceutical formulation and regulatory requirements.
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Project Management:
- Manage multiple projects simultaneously, ensuring timelines and budgets are met. • Identify potential risks and develop mitigation strategies.
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- Prepare project reports and presentations for internal and external stakeholders.
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Qualifications
- Education: BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
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- Experience: 3-6 years of experience in pharmaceutical formulation or compounding (R&D setting preferred).
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- Chewable Expertise: Specific experience with chewable tablets, gummies, or oral disintegrating tablets (ODTs) is a major plus.
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- Technical Knowledge: Deep understanding of excipient functionality, flavor chemistry, and the physical chemistry of solid dosage forms.
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- Regulatory Familiarity: Knowledge of FDA regulations and USP compounding standards.
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- The Startup Mindset: You are comfortable working in a fast-paced environment where priorities can shift, and you enjoy the "build" phase of a product.
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Work Environment
- Laboratory and office settings.
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- May require handling of hazardous materials and adherence to safety protocols.
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- Collaboration with team members and departments to achieve project goals.
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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).
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