(Fixed Term) Specialist, Quality Control

Moderna • Laval, QC

3d • Onsite

About The Position

Joining Moderna means being part of a pioneering team that is revolutionizing medicine with mRNA technology and a broad range of development programs covering various diseases. As an employee, you will be part of a continuously growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with a significant impact on patients' lives worldwide. In Laval, Moderna's strategic partnership with the Canadian Government is transforming the country's pandemic preparedness and response capabilities. Our future state-of-the-art mRNA vaccine manufacturing facility will play a crucial role in ensuring rapid access to vaccines for respiratory viruses, subject to Health Canada approval. We are investing in local talent development and fostering research and development collaborations, thereby strengthening Canada's position as a global center of excellence in mRNA. Moderna is seeking a Quality Control Analyst specializing in Microbiology & Bioassay for our manufacturing site in Laval, Canada. Reporting to the Associate Director of Quality Control, this role involves performing Quality Control testing using various Bioassay and Microbiology techniques in a GMP environment.

Requirements

• BSc/BA in a relevant scientific discipline with 5 years of Quality Control experience in a cGMP organization with a specialization in Molecular Biology, DNA Sequencing, and Microbiology.
• This position is site-based and requires full-time presence at Moderna’s site.
• A minimum of 2 years of work authorization is required for this role.
• Pre-hire and periodic medical evaluations are required for this role.

Nice To Haves

• Hands-on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, and Sanger Sequencing.
• Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others).
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
• Working experience in a GMP environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
• Proven ability to conduct investigations.
• Fluency in French and English as working language.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Responsibilities

• Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, and support ELISA and Cell-Based Potency testing.
• Perform GMP QC Microbiology methods, including Sterility testing, Bioburden Analysis, and Endotoxin.
• Support testing for drug substances and drug products, generating data to support studies as needed.
• Conduct analysis related to Bioassay and Microbiology laboratory, including TOC, Conductivity, Bioburden, Sterility, and Endotoxin testing.
• Participate in method transfer projects for internal and external testing labs and assist in general laboratory operational systems maintenance.
• Provide support during internal and vendor audits, and prepare/ship contract laboratory testing samples.
• Participate in equipment and method qualifications, validations, and method transfers.

Benefits

• Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness, mindfulness, and mental health support
• Family building benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for your future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level