Remote CMC Project Manager

Pharmica Consulting - Boston, MA

Pharmica is seeking a talented CMC Project Manager to play a key role in a client's Pharmaceutical Sciences function in the Boston, MA area . The role will report to the Technical Operations (TechOps) Lead, and we are seeking an experienced individual to drive the delivery of pipeline assets and technical projects. The CMC Project
Manager will be responsible for Clinical-staged programs and project management functions, which includes all Chemistry, Manufacturing, and Controls (CMC) activities for Company ’s programs from GLP toxicology through commercial manufacturing and supply. 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.


About the Role:
• Partner with the TechOps Lead and cross-functional Pharmaceutical Science (PharmSci) team as we manage
multiple, complex activities across Drug Substance, Drug Product, Supply Chain, Quality, Analytical and
Regulatory CMC.
• Partner closely with all key stakeholders of Technical Operations team and external CDMOs to develop and
maintain integrated project plans to identify/communicate interdependencies as well as critical path
activities for the project.
• Conduct scenario planning and provide analysis and recommendations on development plans and
periodically present to TechOps team to ensure alignment.
• Based on PharmSci strategy, (1) prepare and maintain detailed project timelines and dashboards, (2) track
the status of all ongoing development and manufacturing activities and regularly present project status
updates,
• 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 budgeting/forecasting/long-range planning activities for assigned projects
• Facilitate with resource and/or manufacturing constraints at CDMOs

 

The ideal CMC PM candidate will have the following attributes:


• B.S/M.S. or PhD in Chemistry, Chemical Engineering, Pharmaceutical Engineering or related discipline
with 8+ years of pharmaceutical industry project management experience, and PMP is preferred.
• Must have exceptional working knowledge of CMC operations
• Strong Knowledge of Project Management Tools/Software, and demonstrated excellence in project
management and effectively managing multiple projects/priorities. Ensures schedules and deliverables
are met
• Working knowledge of pharmaceutical drug development for small molecule drug substances and drug
products
• Ability to manage multiple priorities in fast-paced drug development teams
• Strategic thinker with good written and verbal communication skills
• Work with functional line to develop and manage budget



Posted On: Friday, October 1, 2021



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