Director, CMC Project Management - Cell/Gene Therapy
Company: Passage Bio
Posted on: November 12, 2019
Job Overview: Passage Bio is seeking a motivated and experienced
CMC Project Manager to support cross-functional product development
- 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
- 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
- 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
- Work closely with CTO, to identify areas of program risk and
collaborate with the project team to propose risk mitigation
- 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
- Work closely with the CTO to track activities and supplies at
our secondary packaging vendor.
- BA or BS degree required; Master's or other advanced degree
- 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
- Practical working knowledge of project management techniques
and concepts as they apply to the biotech/pharmaceutical
- Previous experience managing outsourced contracts and success
at documenting and administering the contract terms and
- Keen attention to detail; exceptional organizational
- Excellent written and oral communication skills.
- Must be able to work independently and within team
- 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
- 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..
Keywords: Passage Bio, Philadelphia , Director, CMC Project Management - Cell/Gene Therapy, Executive , Philadelphia, Pennsylvania
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