Project Manager, Commercial Biotherapeutics Manufacturing | Seattle & Redmond, WA
Just is seeking a technical Project Manager (PM) to provide project management support during the design, build, and validation of a commercial biotherapeutics manufacturing facility in the Seattle area.
The PM will support a multi-disciplinary project team and be responsible for providing integrated planning and task management for this complex project. The Project Manager is expected to be a technical and business subject matter expert in biotechnology CMC operations including broad knowledge of cGMP compliance, manufacturing, process equipment, Quality and quality systems, commissioning, qualification, validation, automation, and electronic systems. The Project Manager will ensure communication flow between workstreams and functions, assist with issue resolution, ensure information transfer between functional areas, as well as, manage the deliverables and timelines. Additionally, the project manager will coordinate governance needs for the project.
The project manager is expected to provide:
Project management skills:
- Solid proficiency with project management methodologies and techniques
- Subject matter familiarity for biologics CMC practices (e.g. manufacturing, Quality, cGMPs…)
- Team facilitation expertise, problem solving, mediation, parameter analysis, team dynamics monitoring
- Auditing and health checks of project teams
- Project timeline scenario modeling
- Team communications, coaching and support
Project coordination skills:
- Critical path analysis, action item and task management and follow up, identifying and clarifying task dependencies, early warning
- Inform the Steering Committee of project status and alerts
Project administration skills:
- Gantt charting, agendas, minutes, communication, and document management
Change management support
The successful candidate will have the ability to facilitate collaboration, effectively work in cross-functional teams, possess strong interpersonal skills and strong written and verbal communication skills. Additionally, the candidate should have excellent presentation, problem solving, risk analysis and critical thinking skills.
- BS in Biological Sciences, Biochemistry, Chemical Engineering, or related field is preferred
- 6-8 years of technical project management experience
- Demonstrable experience with MS Project
- 8-12 years of experience in the biotech industry with CMC experience is desirable
- Experience as the PM for a commercial GMP facility/operation build out including regulatory inspection would be ideal and is preferred.
- PMP certification
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers
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please send resume and cover letter