ttg Talent Solutions ยท 1 week ago
Scientist I/II
ttg Talent Solutions is a fast-growing pharmaceutical research and manufacturing organization expanding its R&D operations. They are seeking motivated Scientists and Associate Scientists to support formulation and analytical development for inhalation-based drug products in a GMP-regulated environment.
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
Qualification
Required
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
Solid understanding of GDP and deviation processes
Preferred
Experience with Empower software for data acquisition and reporting strongly preferred
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