Role:
You will love this role if you have a passion for innovative science and medicine, you thrive in a fast-paced environment and enjoy contributing to drug development in an integrated communicative team environment.
The Quality Control Scientist role is to lead new complex protein industrialization efforts taking the responsibility of developing an adequate analytical control panel and its execution, from R&D to QC level. The incumbent will participate in the analytical development planning ensuring that assays are fit for purpose throughout the assay life cycle and are supportive of the necessary control for manufactured proteins. The QC Scientist will use her/his experience in QC laboratory operations to facilitate assay technology transfers to QC labs contracted to test clinical trial material. In addition, the incumbent will lead the setting of drug substance and drug product specifications for investigational products as well as the preparation of certificates of analysis and testing. A related responsibility is to organize stability data and its trending. The QC Scientist will conduct technical investigations to resolve non-conformities and out of trend and/or out of specification results, as well as have an active participation in the drafting and revision of analytical regulatory sections. Other responsibilities include using best scientific/industrial/regulatory practices in all projects and integrating the analytical development efforts with the process development team.
This is a full-time position that reports to the Associate Director of Analytical Development and is based in Montreal, QC, Canada.
Duties and responsibilities:
- Lead analytical assay qualification / pre-validation in the scope of transfer to QC laboratories
- Lead product specification setting, stability study data trending, and reference standard qualifications
- Responsible for conducting and/or organizing analytical investigations within CMC
- Responsible for analytical technology transfer to QC laboratories
- Lead the development of the assay panel to support product quality during manufacturing
- Participate to product characterization efforts
Qualifications:
- A minimum of a Bachelor of Science (B.Sc.) in biology, biochemistry or equivalent with 10 years of relevant experience
- Practical experience with the development of protein product assays and their validation
- Expertise with Good Manufacturing Practices (GMP) and pharmaceutical regulations
- Expertise in QC lab operations, including release testing under specification, stability studies, reference standard qualifications, and investigations of non-conformities
- Knowledgeable of regulatory (FDA, Health Canada, EMA) requirements for analytical and quality control activities
- Knowledgeable in regulatory analytical section drafting and revision
- Ability to work in cross-functional teams and in a fast-paced environment
- Experienced in problem solving and troubleshooting
- Excellent verbal and written communication skills
Contact:
Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.comquoting “35Pharma Posting QCS0416” in the subject line – we are looking forward to hearing from you!
Keywords: Quality Control, CMC, Analytical Development, Specification Definition, Regulatory Filing, Technology Transfer, cGMP
