Reporting to the Head of Program and Alliance Management, we are seeking an experienced CMC Project Manager to drive the delivery of pipeline assets and technical projects. The position will work collaboratively with functional area leads and their program teams in a fast-paced and exciting environment to assure appropriate CMC planning and timely execution of critical corporate goals. This includes, but is not limited to, process development, analytical development, technical transfer, regulatory documentation, clinical manufacturing, project strategy and CDMO management. This is an exciting and visible role for a highly qualified and motivated individual.
The successful candidate will be results-driven, highly organized and have a proven track record in managing and driving project success within CMC in the pharma/biotech industry, preferably with gene therapy or gene editing programs. Furthermore, the successful candidate will have excellent communication and collaboration skills, broad knowledge of CMC processes, and experience managing internal and external teams.
- Partner closely with CMC function and CDMOs 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 of status and cross-functional impact.
- Facilitate team meetings using project management best practices/tools 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. Develop project management tools/templates to facilitate timely communication and execution of projects.
- Facilitate CMC budgeting/forecasting/long-range planning activities for assigned projects.
- Bachelor’s degree in life sciences, engineering or related field. Advanced degree (MS, PhD or MBA) and/or PMP Certification preferred.
- A minimum of 7-9+ years of experience in the biopharmaceutical/pharmaceutical industry. Previous experience in gene therapy or gene editing preferred.
- A minimum of 5-7+ years of experience in CMC project management of clinical 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. Pre-IND experience is preferred.
Skills / Capabilities
- Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Visio, Outlook). Experience with SharePoint and PM tools (e.g. Office Timeline Pro, OnePager etc.) a plus.
- Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
- Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact. Prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Strong leadership skills, including demonstrated ability to lead a cross-functional team, and to influence at all levels of an 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 if/when needed.