Your day-to-day responsibilities will include: acting as the primary point of contact for projects, facilitating communication and collaboration between internal teams and external CDMOs and CROs, for CMC development, analytical, manufacturing, packaging, and labeling activities.
You will be expected to:
Manage and track timelines, quality, and deliverables for each project and vendor using Excel, SharePoint, Smartsheet, and other project management tools.
Collaborate with the cross-functional internal team to deliver quality products on time.
Proactively identify project risks and work with the relevant internal and external teams towards resolution.
Provide project updates, including issues, risks and potential solutions to senior leadership. Communicate project status and vendor activities to management.
Provide project updates, including issues, risks and potential solutions to senior leadership. Communicate project status and vendor activities to management.
Participate in drafting RFPs, partner evaluation and selection, and in, tracking, managing, and negotiating new contracts, supply agreements, confidentiality agreements and, purchase orders, for new and existing vendors.
Track and review vendor invoices; collaborate and work with the finance department team to process payments.
Lead project meetings and take part in vendor visits and conference calls.
Oversee shipments and storage of GLP, GMP, and clinical materials following SOPs.
Manage internal and external inventory of intermediates, API, investigational products, retain, samples, and clinical supplies
Requirements:
Bachelor's degree in a scientific field such as Chemistry or Chemical Engineering; Project Management Certification is preferred.
2-8 years of experience in a pharmaceutical company, CDMO or CRO; previous experience in pharmaceutical manufacturing project management role is preferred.
Knowledge of applicable GLP, GMP, ICH, FDA, EMA, and MHRA guidance for pharmaceutical manufacturing and testing of oligonucleotides.