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Project Manager

2 months ago

Madison, United States Theery Full time

Responsibilities


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 pm 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
  • 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 and work with the finance 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 our 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
  • Previous experience in manufacturing of ASO, siRNA, or peptides is preferred
  • Experience managing vendor and partner relationships
  • Proficiency with Word, PowerPoint, Excel, SharePoint, Smartsheet, and other project management tools
  • Exceptional organizational and time management skills and the ability to multi-task
  • Excellent written, verbal and interpersonal communication skills, with the ability to effectively interact with diverse teams, both within and outside the company
  • Highly motivated team player with a desire to work in a fast-paced and dynamic environment and contribute to a growing biotech organization
  • Ability to travel on a limited basis (