Bioassay group is responsible for developing, transferring and validating bioassay method for enGene's innovative gene therapy products. Bioassay group also manages CRO for sample testing, including GMP and non-GMP samples.
As a member of bioassay, he/she will be responsible for prepare and review the analytical CMC documents, including but not limit to change controls, data trending, protocols, and reports. He/she will work close with other bioassay colleagues assisting on data analysis and trending. The successful candidate would have the opportunity to make significant contributions in enGene's dynamic environment where self-driven, enthusiastic employees thrive.
Essential Duties and Responsibilities
Effectively interact with internal stakeholders and external CRO
Author and review analytical documents
Participate method and process related OOS and deviation investigations
Assist bioassay data analysis and trending for Drug Substance and Drug Product
Assist bioassay colleagues on CRO contract, PO and invoicing management.
Skills
Strong technical expertise and experience in cell-based potency assays is necessary.
Understand potency assay data analysis using statistical software (e.g., JMP, Prism, PLA) is a plus.
Excellent technical writing skills is essential for analytical CMC documents, including but not limit to change control, method SOP, study protocol and report.
Familiar with regulatory guidance and GMP requirement on analytical method lifecycle management.
Initiative-taking, independent, and results-oriented to complete tasks
Intensely committed to success and getting the job done well in a team environment.
Strong analytical and organizational skills; highly attentive to details, but also the ability to think in terms of big picture strategy.
Contribute to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration.
Required experience and qualifications
MS in Biological Sciences or relevant field plus minimum of 5 years of experience in the biotechnology or pharma industry
In-depth knowledge and experience in analytical method development, and validation, and sample testing for clinical stage programs.
Extensive experience and expertise in analytical document writing in a regulated environment
Experience in analytical techniques, including cell-based assays, ddPCR and ELISA. Familiar with physical chemistry methodology such as HPLC/UPLC and CE-SDS is a plus.
Demonstrated effective organizational, project management and problem-solving skills.
Experience in managing CDMO/CRO relationships and projects is a plus
Excellent oral and written communication skills, ability to communicate clearly and present the findings to various stakeholders