35Pharma is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life-threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of Montréal, Canada, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.
Role:
Reporting to the Vice President, Technical Operations, the Project Coordinator, Biopharmaceuticals supports the Technical Operations team in ensuring that clinical sites are supplied with investigational product, provides support to the project managers in the execution of project and program management, and supports the non-clinical operational aspects of projects to ensure the project deliverables are on budget and on time.
You will love this job if:
- You have a passion for science and drug development.
- You thrive in a fast-paced environment with lots of responsibility and opportunity to learn.
- You are a self-starter who enjoys working as a team player and value good communication.
Main Responsibilities:
Supply chain logistics, drug products
- Work with Clinical Team to understand the needs – for product and labeling – of the different clinical sites.
- In collaboration with Manufacturing:
- Keep track of inventory, do reconciliation, and ensure proper product destruction when required.
- Coordinate with vendors for inventory, labeling and packaging, and shipment to ensure that the clinical sites are supplied with the investigational products.
- Keep track of stability data and ensure that packaging and labeling of the drug product are updated accordingly.
- Ensure compliance with regulations and implement procedures where necessary.
- Interface with the Quality unit regarding product status (quarantined/released) and excursions from established product conditions during storage or shipment.
- Provide periodic updates of inventory level to the Quality unit and other stakeholders.
- Ensure proper insurance and the availability of legal documents needed for shipments.
Support Technical Operations
- Support program and project management by updating schedules and trackers in real time and providing support in meeting organisation and documentation.
- Execution of project management administrative tasks such as issuing purchase orders, managing invoices, tracking payments, gathering requests for proposals, and following up with vendors.
- Execution of shipments to and from vendors that are managed by Technical Operations.
- Support Finance team with tracking invoices, accruals, and discrepancies so that the team can manage the budgets.
- Referencing and formatting of documents and downloading/filing references.
- Organisation of documents on the document filing system.
Qualifications:
- Minimum of bachelor’s degree in health sciences or related degree within life sciences or equivalent experience.
- Experience in clinical drug development, project coordination/management in a pharmaceutical or biotechnology company or a CRO, and GCP/GMP experience will be considered an asset.
- Flexible, independent and self-motivated.
- Excellent oral and written communication skills.
- Ability to prioritize, organize, plan, and successfully execute multiple tasks and priorities simultaneously.
- An unwavering commitment to the highest quality of work, research ethics, and willingness to learn.
- Demonstrated proficiency in required software (Word, Excel, PowerPoint) and other systems (e.g., data storage systems, Quality Management System (QMS)).
Perks:
- Comprehensive group health insurance
- Paid public transit
- Beautiful office space in Montreal’s Old Port
- Onsite yoga and healthy snacks
- A strong team and culture committed to learning and high performance
Contact:
Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting SCPC1115” in the subject line – we are looking forward to hearing from you!