Job Description

Position Summary:
As a Lead Scientist I, you will be part of a diverse bioengineering team focused on defining and executing process optimization and technology development projects within the cell and gene therapy and regenerative medicine field. You will be responsible for leading and executing process development activities for various products or capabilities related to cell and gene therapy. The Lead Scientist I will provide deep technical expertise to increase CCRM\'s capabilities in: process development; integration/automation of upstream and downstream processing; cryopreservation of cell and gene therapy products; ensuring scalability and robustness of processes for future Good Manufacturing Practices (GMP) manufacturing; development of analytical methods for quality control release; and, characterization of cell and gene therapy products.

Responsibilities:

Leads at least one project, involving defining and executing experiments in the field of cell and gene therapy with limited supervision and technical input. This includes definition of tasks, experimental planning and execution, data analysis, documentation, reporting results, providing recommendations, and drafting standard operating procedures based on an assigned project.
Stays up-to-date in identified technology/project areas, as assigned.
Assists in reviewing statements of work for external partners and/or customers based on their specific needs.
Engages external customers and partners to understand and overcome workflow challenges.
Provides guidance and project leadership, as assigned, to junior staff.
Communicates resourcing needs and challenges to the direct manager.
Participates in continuous improvement within the department and facility through participating in initiatives.
Provides scientific leadership within the organization based on the area of expertise.
Drives effective communication within the immediate team, across the organization, and with the leadership team.
Works within project teams to identify and prioritize future project opportunities.
Demonstrates integrity and a positive attitude in daily performance, and establishes credibility to motivate others to do the same.

Requirements:

PhD in bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, or a related field, with 0-3+ years of relevant industry work experience; or MSc with 5+ years of relevant industry work experience.
Expertise with iPSCs is required.
Experience in a biotechnology industry with a particular focus in cell and gene therapy.
Demonstrated solid scientific approach with deep experience in experimental planning, design of experiments, statistical analyses, interpretation, documentation, and communication.

Intermediate to advanced proficiency with computer productivity software (e.g., MS Office, etc.) and a range of technical applications (e.g., JMP, Minitab, FlowJo).
Able to learn and execute projects in areas with no familiarity.
Shows initiative and is able to read and understand literature and translate it into experimental plans as required.

Strong communication and interpersonal skills.
Independent, detail-oriented, self-starter with excellent analytical skills and able to multitask and succeed in a team environment.
Demonstrates flexibility to support research activities outside of normal business hours, as needed.
Able to work primarily on-site in a lab-based role, with people and project leadership responsibilities as directed.

Desired Characteristics:

Experience with process development, process optimization, analytical development and optimization, workflow simplification, and culture intensification for cells and virus production, as applicable.
Experience in immune and/or gene therapy manufacturing production platforms in either wave-mixed (e.g., Xuri bioreactors) or stirred tank reactors (e.g., Xcellere, Dasgip, and Bioflo/BiBLU bioreactors).
Experience in upstream (isolation, activation, transduction, and expansion) and downstream (harvest, volume reduction, buffer exchange, fill, and cryopreservation) processing workflows with immune cell populations and associated challenges.
Experience in downstream processes for clarification, UFDF, and media scouting (chromatography).
Experience in characterization assays for cells and proteins (flow cytometry, cell viability/killing, qPCR, ddPCR, particle measurement, ligand binding, enzyme activity, concentration, etc).
Understanding of the requirements for GMP manufacturing and quality assurance release.
Experience working with customers.

CCRM