Research Associate / Associate Scientist, Process Development
Role
enGene is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program EG-70 is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG). EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company. For more information, visit enGene.com.
Role
enGene Inc. is currently seeking a qualified and motivated candidate who will play a key role in the Chemistry, Manufacturing and Controls (CMC) group. In collaboration with project leaders, the Scientist will provide expertise to a team responsible for hands-on manufacturing process development and optimization to support our product development.
The candidate will work in a dynamic, fast-paced, and highly collaborative environment, as well as perpetuate the company culture that promotes our values (Patient-focused, Integrity, Innovation and Teamwork).
Responsibilities
Skills
Responsibilities
Required Experience & Qualifications
- Plan and conduct relevant in-house characterization studies of the manufacturing process
- Work with and support Contract Manufacturing Organization (CMO) activities
- Represent CMC on cross-functional sub-project teams as assigned by the CMC leadership.
- Work with CMC colleagues to support new drug product formulations and processes to support pipeline development.
- Independently and proactively apply technical skills and functional knowledge to projects and assignments within the team
- Follow documentation practices in accordance with Quality requirements
- Author and review technical documents and reports, quality documents (SOPs, work instruction, batch records), and regulatory documents (IND, CTA)
- Prepare and present presentations to colleagues on a regular basis; actively participates in program and functional team logistics and technical discussions
- Work under limited supervision with periodic data review
- B.Sc. in chemistry, polymer science, pharmacology, or related field, or B.Eng. in biomedical engineering; with a minimum of 5 years of relevant Pharma/Biotech experience.
- M.Sc. in chemistry, polymer science, pharmacology, biomedical engineering, or related field, with a minimum of 2 years of relevant Pharma/Biotech experience
- Ph.D. in chemistry, polymer science, pharmacology, biomedical engineering, or related field, with a minimum of 1 years of relevant Pharma/Biotech experience
- Experience in late-stage drug development and characterization of colloidal formulations. Experience with polymeric nanoparticles, chitosan or gene therapy is an asset
- Experience with a variety of processes: tangential flow filtration/diafiltration, lyophilization, spray-drying, pumps, clean rooms, control systems and others.
- Experience with a variety of analytical methods: NMR, GPC, HPLC, UV-Vis, fluorescence spectroscopy, DLS, DSC, XRD, Karl Fischer titration, gel electrophoresis, microscopy, and others are strong assets.
- Ability to define problems, design and execute experimental plans, analyze data, establish facts, and draw valid conclusions.
- Ability to work in a team environment to meet timelines
- Detail oriented, self-organizing, self-directing, responsible, highly motivated with strong critical thinking and analysis skills
- Excellent oral and written communication skills in English; French is an asset
- Knowledge of regulatory compliance such as GLP, GMP, and GCP is an asset