Research Scientist

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

Employment type
Full-Time

Work arrangement
No