Formulation Chemist
Aspargo Laboratories, Inc. - New York City, NY
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Industry: Pharmaceutical Research and DevelopmentPosition OverviewWe are seeking a highly skilled and motivated Formulation Chemist to lead and contribute to the development of oral liquid dosage forms. The ideal candidate will have expertise in taste masking, nanoparticle formulation, and scaling up to GMP manufacturing. You will collaborate with cross-functional teams to design, optimize, and implement robust formulations for clinical and commercial production.Key ResponsibilitiesFormulation Development:Design and optimize oral liquid formulations, focusing on stability, bioavailability, and palatability.Incorporate taste-masking technologies such as encapsulation, polymer coatings, and flavor systems.Nanoparticle Formulation:Develop and characterize nanoparticle-based drug delivery systems to improve solubility and absorption.Scale-Up and GMP Manufacturing:Transition formulations from R&D to GMP manufacturing, ensuring scalability and regulatory compliance.Collaborate with manufacturing teams to troubleshoot and optimize production processes.Regulatory Support:Prepare documentation for regulatory submissions, including INDs, ANDAs, and 505(b)(2) NDAs.Ensure formulations comply with regulatory guidelines (FDA, ICH, etc.).Cross-Functional Collaboration:Work with analytical, quality assurance, and clinical teams to ensure successful project outcomes.Present technical findings and updates to stakeholders.QualificationsEducation:Bachelor's, Master's, or Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.Experience:Minimum 5 years of experience in pharmaceutical formulation development, particularly oral liquid dosage forms.Proven expertise in taste masking, including techniques such as encapsulation, particle size reduction, and polymer coatings.Hands-on experience with nanoparticle formulation and characterization is highly desirable.Familiarity with scaling up processes for GMP manufacturing.Knowledge of regulatory requirements for drug development (e.g., FDA, EMA).Skills and Competencies:Strong problem-solving skills and the ability to develop innovative solutions for formulation challenges.Proficient in using formulation and characterization equipment (e.g., high-shear mixers, spray dryers, particle sizers).Excellent project management and organizational skills.Effective communication skills for both technical and non-technical audiences.Preferred Qualifications:Experience with automated liquid filling systems and other manufacturing technologies.Knowledge of biopharmaceutical classification systems (BCS) and their application to formulation strategies.Understanding of controlled-release technologies and excipient compatibility studies.What We Offer:Competitive salary and comprehensive benefits package.Opportunities for professional development and growth within the organization.Collaborative and inclusive work environment.Access to state-of-the-art facilities and technologies.Equity participation in pre-IPO pharma / MedTech, commercial stage company
Created: 2025-02-14