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BioTissue · 3 days ago

Scientist, III

Miami, FL

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

BioTissue is seeking a Scientist III to guide the analytical development program and research projects. This role involves supervising experiments, optimizing cell culture and assays, and developing analytical methods to ensure product quality and regulatory compliance.

BiotechnologyHealth CareMedicalMedical DevicePharmaceuticalTherapeutics

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

Analytical testingCell based potency assaysAssay qualification/validationMolecular biology techniquesStatistical Software ProficiencyMicrosoft Office ProficiencyLeadership skillsProblem solving skillsCommunication skillsOrganizational skills

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

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 help 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)