Le/La Scientifique principal(e), Services techniques joue un rle cl dans le soutien des activits de transfert technologique et de mise lchelle entre la R&D; et la production GMP, au sein de lenvironnement CDMO intgr.

Ce poste est responsable de diriger les activits de validation des procds, de grer la documentation scientifique et technique, et dassurer un transfert efficace des connaissances et des procds entre les quipes et les parties prenantes.

Les responsabilits comprennent la prparation de la documentation lie aux tudes de dveloppement, notamment les protocoles, instructions de fabrication, nomenclatures (BOM), dossiers matres de fabrication et rapports sommaires.

Le/la candidat(e) idal(e) contribuera aux initiatives damlioration continue, soutiendra les efforts de gestion des risques et optimisera la qualit des produits grce une solide comprhension technique des procds de fabrication pharmaceutique.

Vos responsabilits comprendront: Soutenir les transferts technologiques internes et les activits de mise lchelle de la R&D; vers les quipements de production commerciale.

Grer le transfert dinformations techniques avec les clients, incluant la ralisation danalyses de risques et lidentification des carts potentiels.

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

Rdiger et rviser les protocoles et rapports techniques ncessaires la fabrication et au conditionnement des lots QbD, des lots de mise lchelle, denregistrement et de validation de procds.

Fournir un soutien technique aux oprations de fabrication pour le dpannage, loptimisation des procds et lvaluation de nouveaux quipements ou technologies.

Participer la slection et la qualification des quipements afin dassurer leur conformit aux besoins de production et aux exigences rglementaires.

Prparer, excuter et finaliser les protocoles de validation de procds ainsi que les rapports associs.

Maintenir une communication claire et cohrente avec les clients tout au long des activits de transfert et de validation.

Identifier les leons apprises partir des problmes de qualit et les appliquer pour soutenir les initiatives damlioration continue des produits et procds.

Comptences et qualifications: Baccalaurat (B.

Ing. ou B.

Sc.) en chimie, en sciences pharmaceutiques ou dans un domaine connexe.

Solide connaissance des procds de fabrication et des quipements.

Excellentes aptitudes en analyse et en rsolution de problmes.

Capacit dmontre diriger des projets de validation de procds.

Bonne comprhension des principes de la qualit ds la conception (QbD) et de la mise lchelle.

Matrise des rglements BPF et des exigences en matire de validation.

Comptence en analyse des causes fondamentales et en valuation des risques.

Matrise de la suite Microsoft Office (Word, Excel, Power

Point, Outlook) et de MS Project.

Capacit travailler de faon autonome et grer des informations confidentielles.

Bon jugement et aptitude prendre des dcisions claires dans son champ de responsabilit.

Ce que nous offrons: Salaire concurrentiel Avantages complets pour la sant REER collectif (avec programme de contrepartie de 4 %) Programme de vacances annuelles et de congs personnels supplmentaires (PTO)



(nous sommes une culture d''quilibre travail / vie personnelle) Programmes de soutien en sant et au mieux-tre (PaE Homewood Health et Telus Health Virtual Care) Possibilits de perfectionnement professionnel Consolidation d''quipe et vnements d''entreprise amusants Et vous vous joindrez une quipe diversifie 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 theintegrated CDMO environment.

This position is responsible for leading process validation activities, managing scientific and technical documentation while ensuring the productive 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: Bachelors 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, Power

Point 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 youll 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.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 worlds most critical challenges.

Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits 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, were obsessed with where it can take you.

To us, its about more than simply accepting your next job opportunity.

Its the fuel that powers every next step of your life.

Its 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 lifejust ask the 300,000 people we employ each year.

Kelly is committed to providing a workplace environment that is inclusive and respects the dignity of those in our workforce.

Consistent with that commitment, Kelly will ensure that persons who are otherwise able to work are not unfairly excluded from doing so based upon any grounds protected by applicable human rights legislation, and will make all reasonable efforts to accommodate the needs of applicants and employees in all employment processes including but not limited to, hiring, advancement, discharge, compensation, or training.

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For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice .

📌 Senior Technical Services Scientist (Montreal)
🏢 Kelly
📍 Montreal