Scientist, III

Position Summary

The incumbent will guide the analytical development program and research projects; supervising experiments conducted by analysts and other trainees. The Scientist III will also be responsible for creating, optimizing and performing cell culture, technical assays and establishing new research techniques in the R&D laboratory in accordance to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Additionally, the Scientist III will develop analytical methods that measure biological activity, ensure product quality, and meet regulatory requirements for clinical and commercial programs.

Essential Duties & Responsibilities

• Drive the design, development, optimization, and qualification/validation of analytical and potency assays for biologics and tissue-based products.
• Study scientifically sound mechanism-of-action (MoA)-based assays that are robust, reproducible, and aligned with regulatory expectations.
• Design and execute stability studies, forced degradation studies, and comparability assessments.
• Collaborate closely with process development, manufacturing, and quality control teams to ensure seamless assay transfer, implementation, and lifecycle management.
• Author and review method development reports, validation studies, filings (IND, BLA, 510k), and responses to regulatory agencies.
• Technical report writing and editing for scientific abstracts, scientific presentations and manuscripts for publications.
• Act as a scientific resource for cross-functional project teams, providing scientific guidance and troubleshooting expertise.
• Perform molecular biology techniques including immunoassays, ELISAs, cell based assays, transfection assays, protein isolation, western blotting, RNA extraction, RT-PCR methodology, histology (tissue preparation, staining and imaging), and immunohistochemistry.
• Authors and manage standard operating procedures (SOPs), work instructions (WIs) and any other applicable laboratory documentation.
• Lead investigations related to Out of Specifications (OOS) and Out of Trend (OOT) and ensure timely closure of records.
• Stay current on regulatory guidance, industry trends, and emerging technologies in analytical testing.
• Present scientific findings to internal leadership, external partners, and regulatory agencies as needed.
• Mentor and supervise junior scientists and analysts in fostering a culture of excellence and innovation in assay development and data analysis.

Skills & Abilities

• Deep knowledge of analytical testing and cell based potency assays.
• Strong laboratory skills including but not limited to tissue culturing, biochemistry, cell biology, biostatistics, and molecular biology.
• Experience with assay qualification/validation under ICH/FDA guidance (especially Q8, Q9, Q10 and Q14) is highly desirable.
• Ability to define Analytical Target Profile (ATP), identify CQAs, and establish control strategies.
• Strong leadership skills with prior experience training scientific staff.
• Strong problem solving, analytical and organization skills with attention to detail.
• Excellent communication skills (oral/written).
• Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional and cooperative environment.
• Uses observational and reasoning to troubleshoot, grasps concepts, patterns and underlying issues.
• Uses past experiences to help identify likely causes and solutions to problems that might otherwise seem to be unique events.
• Uses training and management skills to helps others see patterns and concepts by using examples and analogies that relate well to their own experience and current knowledge level.
• Statistical Software Proficiency (Minitab, SPSS or similar) and Use of Design of Experiments (DoE) for method optimization.
• Microsoft Office Proficiency (Excel, Word, PowerPoint, Outlook and Visio).

Position Expertise/Qualifications

• Ph.D. in Biology, Biotechnology, Molecular Biology, Biochemistry, Bioengineering, or a related science field required.
• 8 or more years of relevant research industry experience, with a proven track record of scientific achievement.