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 join a team performing gene editing, induced pluripotent stem cell (iPSC) reprogramming, and optimizing differentiation processes towards manufacturing compliance through contract services, as well as contributing to experimental design and execution of method development, process development, and cell production projects for internal programs. You will act as a subject matter expert to support other business units, and will mentor junior team members.
You will be involved in ensuring scalability and robustness of allogeneic iPSC processes for future Good Manufacturing Practices (GMP) manufacturing, and development of analytical methods for quality control (QC) release and characterization of cell and gene therapy products.
Responsibilities:

Provide scientific leadership, project management, and operational oversight of assigned projects related to iPSC reprogramming, genome engineering, and differentiation protocols for academic and industry clients.
Responsible for data generation, collection, interpretation and communication of results.
Prepare and follow standard operating procedures and other process documentation.
Attend and present scientific data at internal and external meetings.
Develop and improve your skills and knowledge to successfully support assigned projects.
Work effectively with other team members in a multi-disciplinary environment.
Perform cell culture and analytical testing, as required, for key experimental objectives.
Engage external customers and partners to understand and overcome workflow challenges.
Drive effective communication across the organization.
Work within project teams to identify and prioritize future project opportunities.
Demonstrate integrity and a positive attitude in daily performance, and establish credibility to motivate others to do the same.
Provide guidance and project leadership, as assigned, to junior staff.

Requirements:

PhD in bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, or a related field with 1-3+ years of relevant industry work experience; or, MSc with 5+ years of relevant industry work experience.
Experience in a biotechnology industry with a particular focus in process development, process scale-up, process analytics, analytical product testing, technology transfer, or manufacturing.
Competent in mammalian cell culture (specifically human iPSCs), including passaging, isolation, expansion, cryopreservation and characterization.
Experience with characterization assays for cells and proteins (e.g. flow cytometry, PCR, qPCR, cloning).
Hands-on experience or strong understanding of iPSC reprogramming and differentiation methods.
Hands-on experience with mechanisms of DNA repair used for gene editing (i.e. CRISPR/Cas9).
Solid scientific approach with deep experience in experimental planning, design (DoE), 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).
Excellent communication and intrapersonal skills.
Independent, detail-oriented, self-starter with excellent analytical skills and the ability to multitask and succeed in a team environment.
Must be flexible to support research activities outside of normal business hours, as needed.
Primarily 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.
Experience in immune and/or gene therapy manufacturing production platforms in either wave-mixed (e.g. Xuri Bioreactors) or stirred tank reactors (e.g. DasBOX and Bioflo/BioBLU bioreactors).
Experience in upstream (isolation, activation, transduction, expansion) and downstream (harvest, volume reduction, buffer exchange, fill and cryopreservation) processing workflows with immune cell populations and associated challenges.
Experience in advanced genetic analysis (e.g. NGS) and in using software for genetic design/analysis.
Experience working with customers.
People and team management skills are an important asset.

CCRM