- Develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for company projects
- Serve as the point person to plan, track, and manage areas including process development, analytical development, tech transfer, manufacturing, toxicology, and vendor management.
- Track and monitor key milestones and decision points to drive delivery of project objectives
- Effectively communicate with team members, senior leaders and key stakeholders on the status, objectives, risks, and mitigation plans associated with projects
- Ensure team members are aware of integrated project timelines, and provide timely updates that may have cross-functional impact
- Facilitate team meetings using meeting management best practices to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives.
- Organize and maintain team communications including meeting agendas, minutes, decision logs, tasks lists, and risk analyses / mitigation strategies using preferred technologies
- Effectively manage internal and external resources to achieve project milestones
- Identify gaps in processes, and then work with appropriate parties to develop, and implement solutions
- Ensure the development and use of key project management tools, metrics and team meeting logistics and documentation, to enhance project delivery and information dissemination to the broader program team
- Facilitate short-term and long-range planning activities for CMC/Technical Operations for assigned projects
- Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable
- Bachelor’s degree in engineering, life sciences or related field. Advanced degree (MS, PhD) and/or PMP certification preferred. Additionally:
- A minimum of 7+ years of experience in the biopharmaceutical/pharmaceutical industry. Previous experience in cell and gene therapy preferred.
- A minimum of 5+ years of experience in CMC project management of clinical or commercial pharmaceutical products, and experience managing CDMOs/third parties for process development and cGMP manufacturing.
- Knowledge of biotechnology/pharmaceutical product development process including technical transfer, manufacturing, stability studies, analytical development, regulatory filings, and clinical/commercial operations.
- Self-directed individual with the ability to thrive with limited direction and ambiguity while working successfully in a cross-functional environment
- Must be a solution-based, creative thinker with a strong work ethic, superb organizational skills and attention to detail
- Demonstrated leadership in clinical-stage drug development settings with strong analytical skills and entrepreneurial drive
- Highly collaborative team player who fosters open communication, facilitates mutual understanding and cooperation with all stakeholders
- Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Visio, Outlook). Experience with other PM tools a plus (e.g. Primavera, OnePager, Kidasa, etc.).
- Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
- Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.