Technician R&D l R&D Technician

Qualifications

• Baccalauréat dans un domaine scientifique (préférence pour la chimie).
• Une (1) à deux (2) années d'expérience pertinente, ou une combinaison équivalente de formation et d'expérience, dans le secteur pharmaceutique, la fabrication, le développement de procédés, le transfert technologique ou la validation.
• Connaissance de base des bonnes pratiques de fabrication (BPF/GMP) ainsi que des exigences réglementaires de l'ICH, de la FDA et de Santé Canada.
• Maîtrise de la suite Microsoft Office, notamment Word, Outlook, Excel et PowerPoint.
• Fait preuve d'intégrité et d'un engagement à respecter l'ensemble des réglementations, des politiques et des procédures opératoires normalisées (PON/SOP).
• Capacité à travailler de façon autonome avec un minimum de supervision.
• Aptitude démontrée à travailler efficacement au sein d'une équipe et à faire preuve d'initiative.
• Grand professionnalisme, sens des responsabilités et comportement éthique.
• Déplacements: Des déplacements peuvent être requis afin de visiter des fabricants sous contrat (CMO), ou de participer à des séminaires et à des salons professionnels, au niveau local ou international, selon les besoins.

Ce que cela vous apporte...

English

The opportunity

Responsibilities

• Technology Transfer
• Responsible for completing assigned projects in alignment with project plans, with strict adherence to established protocols and timelines.
• Work closely with tech transfer lead, formulation specialist, contract manufacturer and support all activities related to technology transfer and site transfer projects
• Obtain all pertinent documentation about the products, such as chemical compositions, master batch records, packaging components specifications, test methods, raw material COAs, stability data, release specification, product statements
• Assist in reporting technical summaries at key stages of tech transfer process
• Support design of experimental studies intended to provide supporting data or to resolve technical issues encountered during a project
• Review batch records, investigation reports, change controls, market complaints, validation documents, equipment qualification reports, technology transfer dossiers, stability data, raw material data trend, and CAPAs, in process and finished product analytical data
• Support process improvement projects and troubleshoot manufacturing processes
• Communicate heavily with CMO’s as well as other Medisca functional teams leading to effective resolution of any issues.
• Lab Work
• Collaborate with R&D formulation team regarding the execution of lab, pilot and support commercial process parameters optimization, batch execution, post batch evaluation and analysis
• Troubleshoot and test experimental studies as needed
• Perform and coordinate scientific studies for physical/chemical characterization, API compatibility, stability testing, packaging compatibility
• Troubleshoot customer formulas to support proprietary products (bases, devices & equipment), including the MAZ
• Assist in testing of formulas, base prototypes, compatibility studies, stability studies and documentation
• Assist in lab cleaning, lab inventory management, general lab maintenance and organization
• Technical Support
• Assist all departments with technical questions related to products
• Assist in OOS and customer complaint investigations
• Support technical support services in resolving technical issues and drive the completion of investigations that affect the technical scope, make recommendations for various options that would resolve the issue.
• Assist in literature searches
• Administrative and Project Management
• Maintain/Update project plans with timelines, milestones
• Prepare and review PPQ (Process Performance Qualification) reports, issue change request through quality management system and support validation process
• Understand and apply cGMP requirements and recommendations from regulatory agencies as they relate to the technology transfer of products and processes
• Clearly and accurately document activities
• Assist in reviewing study protocols, results and reports
• Create technical reports as needed
• Assist in reviewing and creating specification sheets and scientific articles
• Assist in any other tasks that may be called upon

Qualifications

• Bachelor’s degree in a Science related field (Chemistry preferred)
• One (1) to two (2) years’ related experience and/or equivalent combination of education and experience in Pharmaceutical Sector/ Manufacturing /Process Development/Tech transfer/Validation
• Basic knowledge of GMP standards, ICH/FDA/Health Canada regulations
• Office (Word, Outlook, Excel, and PowerPoint) required
• Demonstrates integrity and willingness to comply with all regulations, policies, and SOPs
• Works independently with minimal supervision
• Demonstrated ability to work in a team environment and display initiative
• High degree of professionalism, accountability, and ethics
• Travel: Travel may be required for visiting CMO, attending seminars and trade shows either locally or internationally, when needed

What’s in it for you…