Sr. CMC Project Manager

Our Vaccine client located in Boston, MA is growing and looking to add a Manager/ Sr. Manager, CMC Project Management to their team!  PM will work with a cross functional team across Tech Ops, including Manufacturing, Supply Chain, and Assay Development. 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. The CMC Project Manager will also contribute to developing and sustaining effective Project Management business processes within Technical Operations.  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.
  • Support CMC planning for regulatory filings worldwide.
  • 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).
  • Utilize program data in tools that feed into a portfolio view of TOPS activities across CMC product programs.
  • Assist in developing contract manufacturing production and clinical development plans.
  • Lead CMC teams in establishing clear scope of work and drive team towards the delivery of project milestones on time, on budget, and within scope through utilization of project management tools.
  • 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.
  • Ensure adequate plans are in place to mitigate risks and enable opportunities.
  • Effectively communicate progress at all levels and escalate critical issues appropriately.
  • Ensure project sub-teams apply the techniques stated above to their planning.
  • 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 (preferred). 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.
  • Ability to ensure the integrity and accuracy of CMC program information to meet management requirements.
  • Working knowledge of project management practices either from a formal PM background or from extensive experience in managing projects or programs.
  • Skilled facilitator and negotiator with a keen eye for detail.
  • Extensive experience with Microsoft Office (especially Excel, PowerPoint and Project).
***Role is a hybrid role and be able to come into the Boston office a few days a week.