Just is seeking a highly motivated, creative, driven and experienced Project Director that desires a significant opportunity to improve worldwide access to biotherapeutics. Reporting to the Head of Project Management, the Project Director drives the development and execution of high quality, global, integrated cross-functional project plans for one or more products in support of the overall program strategy. The Project Director will be responsible for providing project management support to large molecule discovery, molecule design, process and product CMC development and cGMP manufacturing teams and for driving strategy, planning and decision making. The Project Director is expected to be a technical and business expert in biotechnology CMC operations, including some broad knowledge of discovery concepts, translational medicine, quality and regulatory requirements for US and EU filings.
- In partnership with scientific and technical leaders and as part of the technical team provide project planning, execution, monitoring and reporting support
- Enable and support information and data exchange between Just and its partners and clients.
- Manage and prioritize support of multiple project teams at one time.
- Enable cross company planning with other Evotec business and technical areas
- With Regulatory coordinate the assembly of regulatory filings as needed
- Provide meeting management support including meeting planning, scheduling, facilitation, documentation and outcomes communicated (i.e. Gantt charting, agendas, minutes, communication, and document management)
- Provide project reporting: Critical path analysis, action item and task management and follow up, identifying and clarifying task dependencies
- Provide project Management: Team facilitation, problem solving mediation, critical path and parameter analysis – Facilitate and incorporate lessons learned, best practices, etc.
- Monitor team dynamics and support decision making
- Identify project issues and facilitate resolution, conduct risk management and contingency planning
- Ensure communication flow between groups, assist with issue resolution and ensure information transfer between functional areas. Collaborate and build constructive relationships throughout Just.
- Assist in the establishment of company best practices and tools
Qualifications and Education Requirements:
- Bachelor’s degree in biological sciences, biochemistry, chemical engineering, or related field
- Minimum 8 years of experience in a CMC drug development project management role
- Demonstrated experience in a drug development project management role
- 10+ years of experience in a CMC drug development project management role
- Drug development knowledge with strong understanding of research, preclinical, clinical, manufacturing, commercial and regulatory areas
- Proven record of implementing biopharmaceutical project management tools, methodologies, practices, and infrastructure
- Informed of current biopharmaceutical industry knowledge, news and trends
- Pro-active, team player with strong sense of urgency
- Independent, motivated, team member with experience in a matrix environment.
- Ability to facilitate collaboration, effectively work on cross-functional teams, possess strong interpersonal skills and be capable of interface with the entire organization.
- Excellent presentation, problem solving, risk analysis and critical thinking skills.
- Experience with MS Project, Excel, PowerPoint, Word, OnePager, Smartsheet
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 200 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area.