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