Analyst, Quality Control - Chemistry & Stability

• We are excited to announce that we are expanding our team and have multiple positions available for this role - join us in shaping the future!*
  

The Role:
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually 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 the potential to make a significant impact on patients' lives worldwide.
In Laval, Moderna's strategic partnership with the Canadian Government is reshaping the nation's pandemic preparedness and response capabilities. Our upcoming state-of-the-art mRNA vaccine manufacturing facility will play a crucial role in ensuring rapid access to vaccines for respiratory viruses. We're dedicated to investing in local talent and fostering research collaborations, strengthening Canada's role as a global mRNA excellence center.
Moderna is seeking a Quality Control Analyst specializing in Chemistry & Stability for our manufacturing facility in Laval, Canada. Reporting to the Associate Director of Quality Control, this role will focus on cGMP QC testing, supporting Global GMP stability programs, and maintaining stability databases. The candidate will be responsible for conducting routine analytical chemistry and stability testing, data trending, and statistical analyses.
Here’s What You’ll Do:
Within 3 Months, You Will…

• Perform routine analytical chemistry and stability testing using techniques such as HPLC, UPLC, GC, UV, Particle Analysis, KF, etc.
• Begin HPLC and NaOH plate reader-based assays in support of manufacturing process stat testing.
• Maintain cGMP documentation for work performed and assist with general laboratory support activities.
  

Within 6 Months, You Will…

• Establish and maintain a safe laboratory working environment, including sample management and equipment maintenance.
• Execute responsibilities in compliance with stability program SOPs, including creating, reviewing, and revising stability protocols and reports.
• Perform stability set down, stability pull activities, and manage QC lab supplies.
  

Within 12 Months, You Will:

• Assist with creating stability schedules for GMP stability drug substances and products, ensuring timely sample distribution to test labs.
• Perform trending of stability data, maintain stability tables and charts, and execute stability sample shipments to external labs.
• Support review and authoring of stability sections for regulatory submissions, and assist with troubleshooting assay methods and equipment.
  

Here’s What You’ll Bring to the Table:

• BA/BSc in Chemistry (preferred) or other relevant scientific discipline.
• Working experience: at least 5-7 years in quality control laboratory of a pharmaceutical company.
• Fluency in French and English as a working language.
• Nous sommes ravis d'annoncer que nous agrandissons notre équipe et avons plusieurs postes disponibles pour ce rôle - bâtissons l'avenir ensemble!*
  

Le rôle:
Rejoindre Moderna, c'est saisir une occasion unique de faire partie d'une équipe pionnière qui révolutionne la médecine grâce à la technologie de l'ARNm. Notre portefeuille varié comprend plusieurs programmes de développement ciblant diverses maladies. En tant que membre de notre équipe, vous contribuerez à une organisation en pleine expansion, collaborant avec des collègues hors pair et des partenaires stratégiques à travers le monde, tout en apportant votre pierre à l'édifice des initiatives de santé globales. Chez Moderna, notre dévouement à repousser les limites de la technologie des médicaments à ARNm promet une carrière stimulante et enrichissante, offrant la chance d'impacter significativement la vie des patients partout sur la planète.
À Laval, le partenariat stratégique de Moderna avec le gouvernement canadien est en train de transformer les capacités de préparation et de réponse du pays aux pandémies. Notre future installation de production de vaccins à ARNm de pointe jouera un rôle crucial en garantissant un accès rapide aux vaccins pour les virus respiratoires. Nous nous engageons à investir dans le talent local et à encourager les collaborations de recherche, renforçant ainsi le rôle du Canada en tant que centre mondial d'excellence en ARNm.
Moderna, à l'avant-garde de l'innovation biomédicale, est en quête d'un Analyste qualifié en Contrôle de Qualité, spécialisé en Chimie et Stabilité, pour notre établissement de pointe à Laval, Canada. Sous la direction du Directeur Associé du Contrôle de Qualité, ce poste clé se consacrera aux essais de contrôle qualité conformes aux Bonnes Pratiques de Fabrication (cGMP), en appui aux programmes globaux de stabilité GMP et à la gestion efficace des bases de données de stabilité. Le candidat idéal aura la charge de mener des analyses chimiques régulières et des tests de stabilité, tout en effectuant des analyses de tendance et des évaluations statistiques approfondies.
Voici ce que vous ferez :
Dans les premiers 3 mois, vous...

• Effectuerez des analyses chimiques et des tests de stabilité standards, utilisant des techniques avancées telles que HPLC, UPLC, GC, UV, analyse de particules et KF.
• Initierez des essais HPLC et des analyses via lecteur de plaque NaOH, cruciaux pour les tests de statut des processus de fabrication.
• Assurerez la gestion rigoureuse de la documentation cGMP pour toutes les opérations effectuées et contribuerez activement au support général du laboratoire.
  

Au cours des 6 mois suivants, vous...

• Instaurerez et préserverez un environnement de laboratoire sécurisé, incluant la gestion minutieuse des échantillons et la maintenance des équipements.
• Serez responsable de l'application stricte des SOP pour les programmes de stabilité, incluant l'élaboration, la révision et l'actualisation des protocoles et rapports de stabilité.
• Organiserez et superviserez les procédures de mise en place et de suivi des tests de stabilité, tout en gérant les approvisionnements du laboratoire QC.
  

À l'issue des 12 mois, vous...

• Contribuerez à l'élaboration des calendriers de stabilité pour les substances et produits GMP, garantissant une distribution efficace des échantillons aux laboratoires d'analyse.
• Réaliserez des analyses de tendances sur les données de stabilité, maintiendrez à jour les tableaux et graphiques pertinents, et gérerez l'envoi d'échantillons de stabilité aux laboratoires externes.
• Jouerez un rôle essentiel dans la révision et la rédaction des sections de stabilité pour les dossiers réglementaires et assisterez dans le dépannage des méthodes d'essai et des équipements.
  

Voici ce que vous apporterez :

• BA/BSc en Chimie (préférable) ou autre discipline scientifique pertinente.
• Expérience professionnelle : au moins 5-7 ans dans un laboratoire de contrôle de qualité d'une entreprise pharmaceutique.
• Maîtrise du français et de l'anglais en tant que langues de travail.
  

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• Location-specific perks and extras!
  

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
]]>