Company: enGene Inc.
Position: Bioassay Manager/Specialist
Location: Montreal, Quebec
enGene Inc. is a high growth biotechnology company developing a robust, proprietary non-viral vector platform to deliver genes to various epithelial tissues. The vector system can be administered to the intestine via the oral or enema route, or the bladder via instillation. enGene is developing its unique gut optimized gene delivery formulation into an orally available “Gene Pill™”, which has the potential to be a platform for oral delivery of a wide range of therapeutic protein drugs. The Company’s primary focus is to apply its technology to enable localized delivery of therapeutic proteins to the gut and other epithelial tissues for treating various disorders.
enGene Inc. is currently seeking a qualified and motivated candidate who will play a key role in the BioAnalytical group. The successful candidate will report to the Director of R&D. In collaboration with project leaders, the BioAssay Manager/Specialist will provide expertise to a team responsible for developing, optimizing, validating and performing assays to generate preclinical data for drug development. The BioAssay Manager/Specialist will work in a dynamic, fast-paced and highly collaborative environment. The BioAssay Manager/Specialist will also contribute to perpetuate the company culture that promotes our values (Patient-focused, Integrity, Innovation and Teamwork).
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Responsible for the development, implementation, optimization and validation of multiple bioanalytical assays using the best industry practices to support non-clinical and clinical drug development programs.
• Provide technical guidance to internal Research Associates (RAs) working on bioanalytical projects, either in an advisory capacity or as a direct supervisor.
• Stay up-to-date with the latest molecular biology, cellular biology, and other relevant technologies for supporting bioanalytical activities.
• Represent the bioanalytical function on program teams and contribute to proper bioanalytical support for these programs; frequently act as a resource and provide guidance to colleagues. Interact with project leaders, other function leads and a team of dedicated scientists.
• Interact with CROs as needed. This may include new technology assessment, methods validation/troubleshooting, sample testing/analysis, reports reviewing and regulatory compliance.
• Participate in inter-departmental meetings with Quality Control management and SMEs.
• Facilitate a proactive management approach with open communication lines, ensure good documentation (SOPs writing/compliance and maintenance of lab notebooks) and up-to-date training of laboratory personnel.
• Author/contribute/review protocols, non-clinical and clinical study reports, regulatory documents, and manuscripts for publication.
• Provide mentoring and individual career development plans for direct reports, as appropriate.
• Perpetuate the enGene company culture that promotes creativity, open communication, and collegiality; one in which projects are run with a sense of urgency that is recognized by all team members.
EXPERIENCES AND QUALIFICATIONS
• MS with 8+ years of industry/regulated laboratory experience with bioanalytical assays, or PhD with 5+ years of relevant postdoctoral experience (industry/regulated laboratory experience is preferred).
• Previous experience(s) leading a team and managing bioanalytical assays represents a significant asset.
• Hands-on experience and understanding of molecular and cellular biology, transfection methods, flow-cytometry, microscopy techniques and immunological assays are highly desirable.
• Experience in working with CROs on bioanalytical projects, managing timelines and deliverables in support of preclinical and clinical drug development studies is desired.
• Experience with mucosal epithelial surfaces, including work with primary cells, is a strong asset.
• Experience in Inflammatory Bowel Diseases (IBD) and/or Bladder cancer is an asset.
• Knowledge of global regulatory guidelines, expectations and corresponding industry’s best practices is an asset.
• Team-focused, goal-oriented and quality-conscientious.
• Ability to work in a fast-paced and dynamic team environment.
• Ability to develop solutions to diverse challenges within cross-functional teams.
• Demonstrated leadership skills.
• Proven ability to work under pressure with tight timelines.
• Demonstrated ability to present scientific information, data/conclusion and strategies with influence to a variety of audiences.
• Excellent verbal and written communication in English (French represents an asset).
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