Senior Research Scientist

Purpose

The Senior Research Scientist is responsible for spearheading research initiative and driving the development of new products through expert scientific knowledge. The role includes managing project schedules, design of experiments, process development, project budget, and successful project completion.

Responsibilities

• Develop and execute research projects from product concept to market launch focusing on innovation in human cells, tissue products (from cadaveric or live donation), medical devices, and biologics
• Lead comprehensive research projects based on exhaustive review of peer-reviewed literature, project execution, data analysis, and verifying applicable standards & regulations are met to ensure successful completion of research development projects
• Manage and mentor Research Scientists and Associates to ensure studies are executed within the scope of a specified project, providing both scientific expertise and operational support
• Track and report research project progress, ensuring milestones are achieved and communicated effectively to leadership and stakeholders on a weekly basis
• Work independently on complex research projects and exercise independent thinking and judgment without established protocols and procedures
• Design and execute a variety of scientific experiments related to research projects by generating, collecting, evaluating, and interpreting statistically significant data for critical decision-making and product launches, using in vitro and in vivo assays
• Work closely with the Research Manager to develop strategic project plans and set research priorities
• Develop guidelines, operating procedures, forms, protocols, reports, proposals, statements of work, presentations, verifications, qualifications, among other research project related documents
• Author and review manuscripts and white papers for publication and provide marketing team with scientific data and insights
• Maintain the budget and promote general operational efficiency for their assigned research project
• Establish working relationships with new and existing vendors to source testing, equipment, supplies, materials, or other resources
• Implements quality assurance practices in the design and execution of project activities
• Support Project Engineers in the scaling of manufacturing processes and resolution of manufacturing issues
• Carry out general laboratory, equipment, and material tracking and maintenance of department resources
• Engage and foster collaboration with key stakeholders (ex. medical or scientific collaborators) and cross-functional teams to align research projects with organizational goals and expectations
• Responsible for all aspects of assigned research projects, and performs all other duties as assigned
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned

Skills

• Strong organizational, multitasking, and detail-oriented skills with the ability to meet tight deadlines
• Excellent verbal and written communication skills for effective collaboration and complex scientific discussions
• Capable of working independently or part of a team, adapting to changing project requirements
• Advanced troubleshooting skills with a solution-oriented approach to technical challenges
• Strong analytical abilities, proficient in statistical software (e.g., GraphPad) and Microsoft Office Suite (Excel, Word, PowerPoint)
• Experienced in planning and executing experiments using complex laboratory instruments and software
• Strong responsiveness and flexibility to successfully adapt to changing priorities
• Highly self-motivated with a focus on quality and precision in research activities
• Ability for travel for company meetings within the United States

Qualifications/Requirements

• Master’s degree with a thesis in a scientific discipline (e.g., biology, bioengineering, biochemistry) with 7-8 years of post-master\'s research experience, or a Doctoral degree with 5 years of post-doctoral experience preferred
• Experience in laboratory practices, academic or industry
• Experience in technical writing, with contributions to peer-reviewed manuscripts, technical reports, grant submissions
• Experience in human cell and tissue products is preferred
• Minimum of 4 years’ experience in project management and 5-6 years research & development/product development
• Clearance of favorable background investigation required