Purpose
The Research Scientist is responsible for leading the investigation and development of innovative human cells, tissues, and cellular based products. They will own all aspects of the assigned projects, including scheduling, experimental design, process development, and budgeting, while also supporting the Product Development and Marketing teams.
Responsibilities
- Own & develop project deliverables for new product technologies, process improvements, and product characterization
- Manage project activities, maintain schedules, and provide weekly updates
- Collaborate with key stakeholders (ex. medical or scientific collaborators), department staff and other teams to execute research projects
- Support Project Engineers in scaling manufacturing processes and resolving issues
- Process human cells, tissues, and cellular based products from cadaveric or live donations as needed
- Conduct literature reviews, design and execute experiments, analyze data, and ensure compliance with scientific and regulatory standards
- Train associate research staff in lab and documentation best practices
- Perform in vitro or in vivo assays (in-house or externally sourced)
- Develop, validate and implement assay protocols and procedures for new test methods
- Prepare research-related documents including protocols, reports, proposals and presentations
- Operate and maintain scientific test equipment
- Maintain laboratory resources and materials
- Establish and manage relationships with vendors for sourcing testing equipment
- Implement quality assurance practices in the design and execution of project activities
- Uphold integrity and maintain responsible conduct of research to ensure compliance and ethical standards are met in all research activities
- 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
- Highest level of ethics and integrity
- Excellent verbal and written communication skills for effective collaboration and complex scientific discussions
- Strong organizational, multitasking, and detail-oriented skills with the ability to meet tight deadlines
- Strong understanding of the intersection between scientific research, product development, and business strategy
- Capable of working independently or part of a team
- Effective project management skills, from planning through execution and completion.
- Ability to multi-task and work in a fast-paced environment
- Strong technical writing
- Ability to multi-task and work in a fast-paced environment
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and statistical software
Qualifications/Requirements
- Doctoral degree in a scientific discipline with 3 years of post-doctoral experience plus 1 year of industry experience required
- Master’s degree with a thesis in a scientific discipline plus 3 years of industry may be substituted to meet doctoral degree requirements
- At least 2 years of project management experience required
- At least 3 years of research and development experience required
- Experience in technical writing, with contributions to peer-reviewed manuscripts, technical reports, grant submissions
- Experience using complex statistical computer software (ie GraphPad Prism)
- Experience in tissue banking is preferred
- Clearance of favorable background investigation required
