CCRM Careers

Description

Position Summary: 

As Lead Scientist II (LS II), 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, with internal and some external client-facing focus, upstream and downstream process development activities for various products related to cell and gene therapy. The LS II will provide deep technical expertise to increase CCRM’s capabilities in at least two of the following: 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, and the development of analytical methods for quality control (QC) release and characterization of cell and gene therapy products.

Responsibilities: 

• Provides scientific leadership within the organization, for management and in cell and gene therapy project execution.
• Leads one or more projects and independently defines and executes experiments, including defining tasks, experimental planning, experimental execution, data analysis, documentation, reporting of results, providing recommendations, and drafting standard operating procedures based on assigned projects.
• Trains and leads a small team to execute on project milestones based on projects, as assigned.
• Assists in drafting and reviewing statement of work for external partners and/or customers based on their specific needs.
• Engages external customers and partners to understand and overcome workflow challenges, and independently prepares and presents milestone-based data to external customers and partners.
• Works with project teams and/or management to identify and prioritize future project opportunities.
• Drives effective communication across the organization and management team.
• Demonstrates integrity and a positive attitude in daily performance and establishes credibility to motivate others to do the same.
• Provides guidance, mentorship and project leadership to junior staff, as assigned.

Requirements:

• PhD in bioengineering, chemical engineering, bioprocess, biotechnology, cell biology or a relevant field with 2-4+ years of relevant industry work experience, or MSc with 8+ years of relevant industry work experience required.
• Experience in the biotechnology industry with a particular focus in process development, process scale-up, process analytics, analytical product testing, technology transfer or manufacturing.
• Experience in downstream processes for clarification, ultrafiltration/diafiltration and chromatography.
• 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. Minitab, FlowJo, Unicorn).
• Excellent communication and interpersonal skills.
• Independent, detail-oriented self-starter with excellent analytical skills and able to multitask and succeed in a team environment. People and team management skills are an important asset.
• 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.

Desired Characteristics: 

• Experience with process development, process optimization, analytical development and optimization, and workflow simplification for virus production and purification, where applicable.
• Experience in viral vector manufacturing production platforms in either wave-mixed (e.g. Xuri Bioreactors) or stirred tank bioreactors (e.g. Xcellerex, DASbox and Bioflo/BiBLU bioreactors).
• Experience in characterization assays for cells and proteins (flow cytometry, cell viability/killing, qPCR, ddPCR, particle measurement, ligand binding, enzyme activity, concentration, etc.).
• Knowledgeable about the requirements for GMP manufacturing and quality assurance release.
• Experience working with customers.

Revision Number: CCRMLSII-20241003

CCRM is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

CCRM is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.