Director of CMC Project Management

Passage Bio is seeking a motivated and experienced CMC Project Manager to support cross-functional product development teams.

Responsibilities:

CMC Program Manager will lead cross-functional teams within Technical Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files for successful launch and ongoing commercial supply.
Experience in Cell/Gene therapy development/manufacturing
Drive team accountability for deliverables, develop and deliver team recommendations to senior management, create and meet all project milestones
Responsible for delivery of CMC activities up to and including new product launch and post launch improvements. Experienced skills with Process Scale-up, Technology Transfer, Assay Transfer as required, packaging/labeling and process improvements.
Establish and maintain mechanisms to track progress and completion of CRO deliverables and obligations for analyzing in vivo studies from Discovery Research through human clinical trials and commercialization.
Manage relationship with external vendor and resolve issues of moderate to high complexity.
In a matrixed environment, interface cross functionally in prioritizing assigned product support activities. Identify areas of risk to development timeline, clinical operations, regulatory, and other contributing departments to drug development.
In collaboration with the CTO, deliver project/program updates to project team and/or to senior leadership as necessary and appropriate.
Work closely with CTO, to identify areas of program risk and collaborate with the project team to propose risk mitigation strategies.
Under the direction of the CTO, manage contracts with CROs for outsourced activities, including contract changes, issue resolution, contract clarifications, and study reports.
Work closely with the Project Manager at the GTC to understand CMC activities, timelines, and impact to planned development activity.
Work closely with the CTO to track activities and supplies at our secondary packaging vendor.

Requirements:

BA or BS degree required; Master’s or other advanced degree preferred.
5-10 years of CMC project management experience in the life sciences and/or biotech/pharmaceutical industry. The ideal candidate will have experience in CMC project management, operational planning, and/or contracts management. Experience with IND regulatory submissions and/or Phase 1 clinical trials is particularly desirable.
Practical working knowledge of project management techniques and concepts as they apply to the biotech/pharmaceutical industry.
Previous experience managing outsourced contracts and success at documenting and administering the contract terms and requirements.
Keen attention to detail; exceptional organizational skills.
Excellent written and oral communication skills.
Must be able to work independently and within team environments.
Ability to prioritize tasks, adapt to shifting priorities, and deliver on projects in a timely manner.
Ability to capture technical discussion in the form of meeting minutes, decision points and action items.
Experience working in cross-functional product development teams and in particular in a scientific or clinical setting is desired.
Ability to confidently and respectfully interact with all levels of management.
Experience in regulatory affairs, clinical operations, and/or manufacturing is additionally desirable.
Proficient in relevant software: MS Project or other project management software, Excel, PowerPoint, Word, Access, etc. in addition to general knowledge with shared work environments.