CMC Project Manager

Our Vaccine Client in Boston, MA is growing and looking to add a CMC Project Manager to their Technical Operations team (Hybrid onsite & WFH)! This role will work cross functionally across Tech Ops, including Manufacturing, Supply Chain, and Assay Development.

Will be a member of the core program team representing CMC and partner with Tech Ops and other leaders in the development and implementation of CMC project strategies and comprehensive project plans.

CMC PM will plan for Tech Ops related activities; manage and track key CMC activities; anticipate, resolve, and escalate issues;

coordinate CMC plans with global development and forecasted plans. Responsibilities include but not limited to :

Effectively coordinate cross-functional CMC Team.

Consistent meeting management (agendas, desired outcomes, read-ahead documents, minutes, etc.).

Consistent use of project tracking tools (Primavera, MS Project, dashboards, etc.).

Plan / manage / track key CMC activities, including identifying responsible individuals.

DS, DP, API labeling and packaging.

Regulatory submissions, including the tracking of INDs (and the comparable filings on a country-by-country basis) approved in particular countries and the timing for introduction of clinical products.

Coordinate CMC program plans with global distribution plans.

Monitor contractor status, including the tracking-to-closure of CMO deviations.

Anticipate, escalate and resolve issues as appropriate (technical, processing, compliance, resource and facility / equipment issues).

Assist in developing contract manufacturing production and clinical development plans.

Build fully integrated project schedules capturing all activities and resources needed to deliver against corporate goals.

Monitor project progress and identify risks and opportunities to timeline, budget or scope.

Effectively communicate progress at all levels and escalate critical issues appropriately.

Coordinate and lead internal and CMC-Vendor meetings, and document and communicate key takeaways to relevant constituents.

Requirements :

Bachelor’s Degree in a scientific / engineering discipline required; advanced degree in science / engineering or MBA preferred.

5+ years’ of relevant industry experience, particularly in the development of vaccines. Must have experience with managing clinical pharmaceutical products from a project management and supply chain perspective.

Experience with recent regulatory trends is preferred.

2+ years’ of experience within a CMC function or group with hands-on experience in late phase drug product development or 2 years’ of specific CMC project management experience with complex manufacturing development processes.

Working knowledge of project management practices either from a formal PM background or from extensive experience in managing projects or programs.

Extensive experience with Microsoft Office (especially Excel, PowerPoint and Project).

This is a hybrid role and will be in office (Boston) 2-3 days a week and the rest work from home.