Scientist I/II (GMP)

ttg Talent Solutions; Town of Florida (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

ttg Talent Solutions is expanding its R&D operations and seeks motivated Scientists and Associate Scientists (Levels I & II) to support inhalation drug product formulation. These roles emphasize analytical method development and troubleshooting in a GMP-regulated environment.

Candidates should have a relevant degree and hands-on GMP laboratory experience, as well as proficiency with HPLC, UPLC, and GC. This position offers a chance to mentor junior scientists and improve laboratory compliance.

Qualifications

• Minimum 1 year of hands‑on GMP laboratory experience required.
• Proven experience with chromatographic systems.
• Working knowledge of GMP/GLP and FDA regulatory expectations.

Responsibilities

• Perform routine and advanced analytical testing of products in compliance with GMP.
• Support development of formulations for inhalation drug products.
• Operate and troubleshoot analytical instruments.

Skills

Chromatographic systems (HPLC, UPLC, GC)

Analytical testing

Attention to detail

Documentation skills (GDP)

Education

PhD, MS, or BS in Analytical Chemistry

Tools

Empower software

Analytical instruments (HPLC, UPLC, GC, UV, FTIR)

Job description

Pay Rate: Competitive - commensurate with experience and technical proficiency

Department: Research & Development - Analytical & Formulation

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 Scientists and Associate Scientists (Levels I & II) to support formulation and analytical development for inhalation-based drug products, including MDI, DPI, and nasal spray formulations.

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.

Key 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 strongly preferred.
• Solid understanding of GDP and deviation processes.

Preferred Attributes

• Prior exposure to regulated audits (FDA, EMA, MHRA) is advantageous.
• Experience in method validation or transfer projects a plus.
• Strong analytical thinking, data review, and problem‑solving skills.
• Excellent communication and teamwork abilities.
• High attention to detail, organization, and quality compliance.

At ttg, 'We believe in making a difference One Person at a Time,' ttg OPT.