Senior Research Scientist
Apply NowCompany: Extremity Care
Location: San Antonio, TX 78228
Description:
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
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