Job Description

About CellCarta

CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with over 1000 employees in its nine facilities located in Canada, USA, Belgium, Australia, and China.

Summary

The Director of Assay Development is responsible for the development of flow cytometry assays that meet the intended purpose in the scope of the clinical trial(s). They manage and mentor a team of scientists and research assistants for the development of custom assays, standard panel set-up, assay characterization and fit-for-purpose validation of exploratory studies, as well as provides guidance for effective testing design and troubleshooting of technical issues encountered in development. They provide scientific/technical leadership within the development team, as well as the scientific team (principal scientists), within CellCarta organization, at scientific meetings and with CellCarta customers. They are responsible also to ensure that the assays developed and characterized in development are robust enough to meet the required operational excellence level. They lead the development team as a "SWAT" unit for assays deployed by the immune monitoring team, they are equally responsible to represent CellCarta at scientific meetings and to provide support to business development at the scientific/technical level. The Director of Assay Development may be required to lead or participate at the implementation of new technologies as well as enhance existing or implement new flow cytometry protocols.

Responsibilities

• Oversees scientific/technical design and delivery of the projects according to set timelines
• Ensures that the assignment of projects is appropriate, based on the technical skill set of the scientist
• Ensures that the development as well as panel set-up in terms of testing design is performed appropriately by the scientists
• Provides oversight to the technical design as well as conclusions to the data
• Ensures that the planning of studies is efficient, and deliverables are met
• Leads troubleshooting activities along with the development scientist by assisting and mentoring members of the development team
• Assess and implements a streamlined approach to assay development by identifying areas of improvement and leads the effort of optimisation
• Assesses and implements new protocols for flow cytometry assays that maintain CellCarta within industry standards
• Stay abreast of current best practices in flow cytometry and immunology
• Review and approve the documentation (e.g. workplans, reports) from development studies
• Actively supports Business Development with new client meetings for the scientific aspect and assay design of future work as well as scientific meetings
• Actively participates in assay plan design and scientific writing of client proposals
• Attends scientific conferences as required - Present summary of each event attended.
• Participates in the preparation of presentations and publications in collaboration with clients when possible
• Interact with the Data Analysis Unit and Principal Scientists in the development of new assays as per client needs, including the assay validation phase
• Makes recommendations for new platforms and processes.
• Responsible of performing annual performance review of staff directly under his supervision
• Responsible for staff development and learning for the whole unit.
• Identifies and implements performance indicators within the scientific team.

Special Conditions of the Current Position

• Must be willing to supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous viruses such as HIV, HCV, or CMV.
• Employee is personally responsible for following Health and Safety guidelines/instructions.

Education

• PhD diploma in Immunology, with> 3 years post-doctoral training.
• Minimum of 5 years of experience in Pharma/CRO industry.

Experience and Skills Required

• Demonstrated understanding of drug development (discovery, preclinical and clinical phases).
• Working understanding of biomarker assays in support of drug development.
• Long standing (>10 years) experience with flow cytometry techniques and applications in the field of immune monitoring including assay design as well as handling complex data set of multi-color panels.
• Expert level proficiency in working with third party flow cytometry data analysis packages and Microsoft Office products.
• Strong knowledge of current validation requirements for cell based analysis.
• Strong knowledge and understanding of GLP/CAP/CLIA regulations and other regulatory guidelines.
• English and French proficiency (written and spoken) is required.
• >4 years of experience in people management or demonstrated ability to manage people.
• >4 years of experience in project management.
• Demonstrated ability to work independently and as a team.
• Demonstrated ability to lead a team by gathering consensus and then make decision on the path forward.
• Works methodically and systematically.
• Works independently (and in a team situation).
• Critical and creative thinker.
• Advanced level of understanding and analytical skills to interpret data and draw conclusions.
• Ability to see patterns and challenges across projects and studies.
• Communicate clearly and confidently and has excellent interpersonal and teaching skills.
• Ability to manage tense situations constructively and maintain good relationship with internal/external clients.
• Ability to present high-level summaries to senior management.
• Ability to defend ideas in a convincing and professional manner.
• Excellent time management and organizational skills to meet deadlines in a fast-paced, changing environment.
• Excellent record keeping, attention to detail.
• Ability to perform quality review of various documents (workplan, reports, SOP/CSP, deviations).
• Ability to prepare/review and critique reports.
• Ability to design and implement new processes and documents.
• Ability to identify and implement solutions to existing issues.

Powered by JazzHR

CellCarta