Senior Technical Services Scientist
$90k - $110k per yearMacDonald Search Group
Based in Montreal
The Senior Technical Services Scientist plays a key role in supporting technical transfer and scale-up activities from R&D to GMP manufacturing. 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.
Skills and Qualifications:
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. 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.
Compétences et qualifications:
The Senior Technical Services Scientist plays a key role in supporting technical transfer and scale-up activities from R&D to GMP manufacturing. 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.
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.
- Competitive Salary $90,000-$110,000
- 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!
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. 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.
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.
- Salaire concurrentiel $90,000-$110,000
- 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 !
Vacancy posted 23 hours ago
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