Lead Scientist I

**About CCRM**:
**Job Title**: Lead Scientist I

**Position Summary**:
As a Lead Scientist I (LS 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, with internal focus, upstream and downstream process development activities for various products related to cell and gene therapy. The LS I will provide deep technical expertise to increase CCRM capabilities in at least one 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 GMP manufacturing, and development of analytical methods for QC release and characterization of cell and gene therapy products.

**About CCRM**:
**Responsibilities**:

- Provide scientific leadership within the organization and in cell and gene therapy project execution.
- Perform cell culture and analytical testing as required for key experimental objectives.
- Project execution for optimization and technology development programs in cell and gene therapy with a focus on one or all of the following: process and analytical development, immunotherapy, CAR-T technology, and viral vector technology. This includes definition of tasks, experiment planning and execution, data analysis, documentation, SOP preparation, SOW drafting, reporting results, and providing recommendations.
- Engage external customers and partners to understand and overcome workflow challenges.
- Drive effective communication across the organization.
- Work within project teamsto 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 a relevant field with 1-3+ years of relevant industry work experience or M.Sc with 5+ years of relevant industry work experience required
- Experience in a biotechnology industry with a particular focus in process development, process scale up, process analytics, analytical product testing, tech transfer or manufacturing.
- Experience with characterization assays for cells and proteins (flow cytometry, fluorescence, binding, activity)
- Solid scientific approach with deep experience in experimental planning, design (DoE), statistical analyses, interpretation, documentation and communication.
- Excellent communication and intrapersonal skills.
- 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 and virus production including where 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, Xcellerex, Dasgip, and Bioflo/BiBLU 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 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 QA release
- Experience working with customers

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.

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.