Scientist III

Kelly Science is seeking a Scientist III for a growing company located in Miami, FL. Shift: Monday-Friday 1st ShiftEmployment Type: Full Time; Direct Hire Position Summary:The Scientist III leads analytical development and research projects, supervising lab staff and trainees. Responsibilities include creating, optimizing, and performing cell culture and technical assays, establishing new research methods, and ensuring compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). The role requires expertise in assay development, method validation, and cross-functional collaboration to meet regulatory needs for clinical and commercial programs.Key ResponsibilitiesDevelop, optimize, and validate analytical and potency assays for biologics and tissue-based products.Design and conduct stability, degradation, and comparability studies.Collaborate with process development, manufacturing, and quality control teams for seamless assay implementation.Author and review technical reports, scientific abstracts, manuscripts, and regulatory filings (IND, BLA, 510k).Supervise experiments and mentor junior scientists and analysts.Perform a range of molecular biology techniques (e.g., immunoassays, ELISAs, cell-based assays, protein isolation, western blotting, RT-PCR, histology, immunohistochemistry).Manage laboratory documentation (SOPs, WIs).Lead investigations for Out of Specifications (OOS) and Out of Trend (OOT) issues.Stay updated on regulatory guidance, industry trends, and emerging analytical technologies.Present findings to internal teams, external partners, and regulatory agencies. Qualifications: Ph.D. in Biology, Biotechnology, Molecular Biology, Biochemistry, Bioengineering, or related field, with 8+ years of relevant industry experience.Expertise in analytical testing, cell-based potency assays, laboratory techniques (tissue culture, biochemistry, cell biology, biostatistics, molecular biology), and assay qualification/validation under ICH/FDA guidance (Q8, Q9, Q10, Q14).Strong leadership and training experience, problem-solving skills, and attention to detail.Excellent communication and organizational abilities; capable of managing multiple priorities in a fast-paced environment.Proficient in troubleshooting, statistical software (Minitab, SPSS, etc.), Design of Experiments (DoE), and Microsoft Office Suite. Interested? Please apply today for immediate consideration!