Senior Technical Services Scientist

Le/La Scientifique principal(e), Services techniques joue un rôle clé dans le soutien des activités de transfert technologique et de mise à l’échelle entre la R&D et la production GMP, au sein de l’environnement CDMO intégré. Ce poste est responsable de diriger les activités de validation des procédés, de gérer la documentation scientifique et technique, et d’assurer un transfert efficace des connaissances et des procédés entre les équipes et les parties prenantes. Les responsabilités comprennent la préparation de la documentation liée aux études de développement, notamment les protocoles, instructions de fabrication, nomenclatures (BOM), dossiers maîtres de fabrication et rapports sommaires. Le/la candidat(e) idéal(e) contribuera aux initiatives d’amélioration continue, soutiendra les efforts de gestion des risques et optimisera la qualité des produits grâce à une solide compréhension technique des procédés de fabrication pharmaceutique.

Vos responsabilités comprendront:

· Soutenir les transferts technologiques internes et les activités de mise à l’échelle de la R&D vers les équipements de production commerciale.

· Gérer le transfert d’informations techniques avec les clients, incluant la réalisation d’analyses de risques et l’identification des écarts potentiels.

· Traduire les besoins des clients en exigences claires et mesurables, incluant les paramètres critiques pour la qualité (CTQ) des produits et composants.

· Rédiger et réviser les protocoles et rapports techniques nécessaires à la fabrication et au conditionnement des lots QbD, des lots de mise à l’échelle, d’enregistrement et de validation de procédés.

· Fournir un soutien technique aux opérations de fabrication pour le dépannage, l’optimisation des procédés et l’évaluation de nouveaux équipements ou technologies.

· Participer à la sélection et à la qualification des équipements afin d’assurer leur conformité aux besoins de production et aux exigences réglementaires.

· Préparer, exécuter et finaliser les protocoles de validation de procédés ainsi que les rapports associés.

· Maintenir une communication claire et cohérente avec les clients tout au long des activités de transfert et de validation.

· Identifier les leçons apprises à partir des problèmes de qualité et les appliquer pour soutenir les initiatives d’amélioration continue des produits et procédés.

Compétences et qualifications:

· Baccalauréat (B. Ing. ou B. Sc.) en chimie, en sciences pharmaceutiques ou dans un domaine connexe.

· Solide connaissance des procédés de fabrication et des équipements.

· Excellentes aptitudes en analyse et en résolution de problèmes.

· Capacité démontrée à diriger des projets de validation de procédés.

· Bonne compréhension des principes de la qualité dès la conception (QbD) et de la mise à l’échelle.

· Maîtrise des règlements BPF et des exigences en matière de validation.

· Compétence en analyse des causes fondamentales et en évaluation des risques.

· Maîtrise de la suite Microsoft Office (Word, Excel, PowerPoint, Outlook) et de MS Project.

· Capacité à travailler de façon autonome et à gérer des informations confidentielles.

· Bon jugement et aptitude à prendre des décisions éclairées dans son champ de responsabilité.

Ce que nous offrons:

· Salaire concurrentiel

· Avantages complets pour la santé

· REER collectif (avec programme de contrepartie de 4 %)

· Programme de vacances annuelles et de congés personnels supplémentaires (PTO) (nous sommes une culture d'équilibre travail / vie personnelle)

· Programmes de soutien en santé et au mieux-être (PaE Homewood Health et Telus Health Virtual Care)

· Possibilités de perfectionnement professionnel

· Consolidation d'équipe et événements d'entreprise amusants

· Et vous vous joindrez à une équipe diversifiée et multidisciplinaire !


English:

The Senior Technical Services Scientist plays a key role in supporting technical transfer and scale-up activities from R&D to GMP manufacturing within the integrated CDMO environment. This position is responsible for leading process validation activities, managing scientific and technical documentation while ensuring the efficient transfer of knowledge and processes across teams and stakeholders. Responsibilities include documentation related to development studies, such as protocols, manufacturing instructions, bills of materials (BOMs), master batch records, and summary reports. The ideal candidate will contribute to continuous improvement initiatives, support risk mitigation efforts, and enhance product quality through a strong technical understanding of pharmaceutical manufacturing processes.

Your Responsibilities will include:

· Support internal technology transfers and scale-up activities from R&D to commercial equipment.

· Manage the transfer of technical information with clients, including performing risk assessments and identifying gaps.

· Translate customer needs into clear, measurable requirements, including critical to quality (CTQ) parameters for products and components.

· Write and review technical protocols and reports required for the manufacturing and packaging of QbD, scale up, registration, and process validation batches.

· Provide technical support to Manufacturing Operations for troubleshooting, process optimization, and the evaluation of new equipment or technologies.

· Assist in the selection and qualification of equipment to ensure alignment with manufacturing needs.

· Prepare, execute, and finalize process validation protocols and reports in accordance with GMP standards.

· Maintain clear and consistent communication with clients throughout technology transfer and validation activities.

· Identify lessons learned from quality issues and apply them to drive improvements in both existing and future products.

Skills and Qualifications:

· Bachelor’s degree (B.Eng. or B.Sc.) in Chemistry, Pharmaceutical Science, or a related field.

· A minimum of 5 years of experience in technical services.

· Strong knowledge of manufacturing processes and equipment – OSD and/ or Sterile

· Excellent analytical and problem-solving skills.

· Proven ability to lead process validation projects.

· Solid understanding of Quality by Design (QbD) and scale-up principles.

· Strong grasp of GMP regulations and validation requirements.

· Skilled in root cause analysis and risk assessment.

· Proficient with Microsoft Office (Word, Excel, PowerPoint and Outlook), and MS Project.

· Ability to work independently and maintain confidential information.

· Makes independent decisions within defined areas of responsibility.

What We Offer:

· Competitive Salary

· Comprehensive Health Benefits

· Group RRSP (with 4% match program)

· Annual Vacation and additional Personal Time Off (PTO) program (we are a work/life balance culture)

· Health and Wellness Support Programs (Homewood Health EAP & Telus Health Virtual Care)

· Team building and fun corporate events

· And you’ll join a diverse and multi-disciplinary team!

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location and job type. Kelly offers eligible employees a group benefit program that includes extended healthcare (drug plan, professional and medical services), dental, life, and emergency travel assistance. In addition, employees are entitled to holiday and vacation pay in accordance with provincial labour law. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community in Canada.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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