Manager Commercial Packaging Operations
Seagen is seeking a highly motivated candidate to join our team and assist with managing the planning and execution of commercial label and packaging operations for global supply. Expected to have extensive knowledge across many functional areas and resources related to CMC and commercialization activities. You must also be able to build and maintain exceptional partnerships with all internal and external stakeholders and lead discussions, problem-solving efforts, and process improvements to ensure supply goals are met or exceeded.
- Leads and participates with both internal and external teams related to Commercial Packaging Operations, executes on deliverables of the program, ensures follow-up of any action items and other administrative responsibilities as required
- Assist in technical problem solving by collaborating with CMOs and Quality to resolve technical and compliance issues
- Provide support and collaboration on packaging and labeling portion of product development. Including validation projects, qualification protocols, specification and GMP documents.
- Excellent organizational, verbal and technical written communication skills, as well as interpersonal, and negotiation skills are essential
- Skilled commercial packaging and labeling (primary and secondary) operations/project management of small molecules
- Working knowledge of packaging and labeling operations of biologics, and other compounds
- Proficient in MS Word, Excel, Outlook, Powerpoint, Project and other project management tools
- Working knowledge of cGMP and 21 CFR Part 11 is required
- Ability to travel ~10%
- BS/BA Degree in a business or life science field and/or 5+ years of experience in manufacturing operations or supply operations
- PMP credential and experience with latest PM tools, software and processes highly valued