We are seeking an experienced CMC Project Manager or Senior CMC Project Manager to drive the delivery of pipeline assets and technical projects. In this position, you will help drive the overall success of our clinical programs within Technical Operations. The position will work collaboratively with functional area leads and their program teams to plan, track and report the diverse activities managed by Technical Operations. This includes, but is not limited to, process development, analytical development, technical transfer, regulatory documentation, clinical manufacturing, commercial planning, project strategy and vendor management. This is an exciting and visible role for a highly qualified and motivated individual.
The successful candidate will be detail-driven and have a proven track record in managing and driving project success within CMC in the pharma/biotech industry, preferably with cell or gene therapy programs. We are seeking an individual with clear attention to detail, demonstrated emotional intelligence, and willingness to pivot when priorities change. The successful candidate will have excellent communication skills, broad knowledge of CMC processes, and experience managing internal and external teams.
- Partner closely with CMC functional areas to develop and maintain integrated project plans to identify/communicate interdependencies as well as critical path activities for the project.
- 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 or MBA) and/or PMP Certification preferred.
- CMC Project Manager
- A minimum of 5-7 years of experience in the biopharmaceutical/pharmaceutical industry. Previous experience in cell and gene therapy preferred.
- A minimum of 3-5 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.
- Senior CMC Project Manager
- 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.
- Ability to work independently and successfully in a matrix environment. Prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization.
- 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.
- Available to travel both domestically and internationally.
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