Associate Scientist

About the Opportunity

A fast-growing pharmaceutical research and manufacturing organization is expanding its R&D operations in Coral Springs, FL. We are seeking motivated Associate Scientists to support formulation and analytical development for inhalation-based drug products.

These are hands-on laboratory roles in a GMP-regulated environment. Successful candidates will demonstrate strong documentation skills (GDP), attention to detail, and the ability to perform and review analytical work with minimal supervision.

This is an excellent opportunity to be involved in pre-formulation, formulation, analytical method development, data interpretation, troubleshooting, and continuous improvement initiatives.

Responsibilities

• Perform routine and advanced analytical testing of raw materials, in-process, and finished products in compliance with GMP.
• Support the development of formulations (solutions, suspensions, propellant-based systems) for inhalation drug products.
• Operate and troubleshoot analytical instruments including HPLC, UPLC, GC, UV, and FTIR, and manage data through Empower (Waters) software.
• Prepare and review protocols, reports, and SOPs in alignment with quality and regulatory requirements.
• Ensure all documentation complies with Good Documentation Practices (GDP) and data integrity standards.
• Participate in method transfer, verification, and validation activities as assigned.
• Support investigations of OOS/OOT, deviations, and CAPA with accurate analytical input.
• Collaborate cross-functionally during manufacturing trials and scale-up activities.
• Mentor junior scientists and contribute to the team’s technical development.
• Maintain a safe and compliant laboratory environment in accordance with EH&S and corporate policies.

Qualifications

• PhD, MS, or BS in Analytical Chemistry, Pharmaceutics, Pharmaceutical Sciences, Biochemistry, or related discipline.
• Minimum 1 year of hands-on GMP laboratory experience (academic-only exposure will not be considered).
• Proven hands-on experience with chromatographic systems (HPLC, UPLC, GC) and analytical testing.
• Working knowledge of GMP/GLP, USP, ICH, and FDA regulatory expectations.
• Experience with Empower software for data acquisition and reporting.
• Solid understanding of GDP and deviation processes.
• Prior exposure to regulated audits (FDA) is advantageous.
• Experience in method validation or transfer projects a plus.
• Excellent communication and teamwork abilities.
• High attention to detail, organization, and quality compliance.