Project Manager CMC (Remote Initially)
Project Manager CMC
We're proud to support one of the largest biopharmaceutical clients in the US in finding a CMC/quality professional interested in a strategic, remote opportunity overseeing CMC and associated functions for ongoing and new biopharmaceutical products.
The overall scope of this position is the Project Management of CMC development, Package development and Pharmaceutical Technical activities in support of new R&D compounds, Life Cycle Management Programs (LCM) and Industrial technical projects and site transfers supporting commercial products.The position is responsible for coordination of technical aspects of Industrial Development (ID) and Industrial Affairs (IA) Programs as well as organization and alignment with other Our client group divisions (Commercial Global Business Units, R&D, Regulatory, etc.), various internal Our client support laboratories and contract CMO facilities.The Project Manager plans and follows activities as defined by the ID Program Directors and project teams such as:creating project scope documents to gain sponsor and management agreement; creation and maintenance of detailed plans, organizing meetings; reporting actions and follow-up for delivery; Technically maintain product portfolio, support development of new product/line extensions, and support site-to-site process transfer and process upgrade activities for new and existing products.
Additionally, as new products approach the launch stage, the Project Manager, working closely with ID CMC and Packaging Program leads, IA sites, IA Supply Chain and CMO’s (with External Manufacturing) outlines plans and activities, followingto assure support for CMC technical activities oversees Industrial activities required to assure our capability to manufacture and grow these products.The position acts as ID representative to support Business Development opportunities and due diligence reviews, and supports, as IA representative, Alliance Management activities in the region.
Key Duties and Responsibilities:
- Supports Industrial Development Program Directors with planning, coordinating and following activities for the various types of projects outlined above, organizing meetings and preparing project updates for project teams and IA management.Specific duties and responsibilities include, but not limited to:
- Creating project scope documents to gain sponsor and management approval.
- Creating and maintaining detailed timelines and project plans with input from Program Directors.
- Organizing meetings with project teams for status update and action item follow up to ensure adherence to timelines.
- Organizing meetings with sponsors to communicate project updates.
- Creates and maintains project plans with gating
- Prepares summaries of proposals from CMOs/CROs for new projects and presents to management for review.
- Obtains the necessary technical information to support projects at internal Our client sites or CMO/CROs.
- Assists with reviewing and finalizing technical documents such as protocols and reports.
- Assists with reviewing contracts (such as MSAs, Quality Agreements) and quotations to support CMC development projects, Industrial technical projects and internal Industrial Development programs.
- BS/MS in chemistry, pharmacy or science with strong experience in Pharmaceutical development, technical operations and /or manufacturing.MBA a plus.
- Proficiency in MS Office
- Knowledge of project management software
- Solid writing and presentation skills
- Excellent organizational and communication skills.
- At least 5+ years’ experience in technical project management, pharmaceutical development, technical operations and/or manufacturing of various drug product dosage forms.
- Must have prior experience as a project manager of technical projects with demonstrated ability to facilitate multi-disciplined teams.
- Experience with international project teams a plus.
- Quality and/or Regulatory background also highly desirable.
- Knowledge of French language (speak, read and/or write) a plus.