BioTissue Ocular ยท 1 day ago
Scientist, III
Miami, FL, US
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expBioTissue Ocular is seeking a Scientist III to guide the analytical development program and research projects. The role involves supervising experiments, developing analytical methods, and ensuring compliance with regulatory requirements in the R&D laboratory.
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
Responsible for supervising experiments conducted by scientists and other trainees
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
Leads 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
Qualification
Required
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
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
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
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)
Preferred
Experience with assay qualification/validation under ICH/FDA guidance (especially Q8, Q9, Q10 and Q14) is highly desirable
Company
BioTissue Ocular
BioTissue Ocular is the pioneer and leader in regenerative medicine for ocular surface disease.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase