R&D Pharmaceutical Formulation Scientist

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 where applicable, maintaining meticulous documentation for quality assurance.

• Analytical Testing: Conduct and oversee stability testing, dissolution studies, and ingredient assays to ensure product integrity.

• Take ownership of projects from concept through pilot scale, ensuring smooth transfer to production and clear communication with cross-functional teams

• Utilize analytical tools (e.g. HPLC, dissolution testing) to generate meaningful insights that guide formulation decisions and scale-up readiness

• Work across multiple oral dosage forms – including chewables, gummies and ODT’s to improve taste, texture and patient experience

• 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.

Regulatory Compliance: 

• Ensure all formulations comply with regulatory standards and guidelines. 

• Understand 21 CFR FDA drug compliance requirements 

Testing and Analysis: 

• Perform HPLC stability testing, dissolution testing, and other necessary tests to ensure the efficacy and safety of formulations. 

• Create prototypes and samples for further testing and evaluation. 

• Analyze data and interpret results to guide formulation development. 

• Document all experiments and results accurately and comprehensively. 

Quality Control and Assurance: 

• Ensure all formulations meet internal quality standards. 

• Implement and maintain quality control processes throughout the formulation development phase.  

Collaboration and Communication: 

• Work collaboratively with cross-functional teams, including quality control, regulatory affairs, and production. 

• Communicate project status, challenges, and results to stakeholders effectively.

• Stay updated with the latest advancements in pharmaceutical formulation and regulatory requirements. 

Project Management: 

• Manage multiple projects simultaneously, ensuring timelines and budgets are met. • Identify potential risks and develop mitigation strategies. 

• Prepare project reports and presentations for internal and external stakeholders. 

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.

• 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.

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.