Job Description

Technical Leader, MSAT CMC Development


The overall scope of this position is to manage CMC development and Pharmaceutical Technical activities in support of new R&D compounds, Life Cycle Management Programs (LCM), product territory extensions and industrial technical projects. As a a member of MSAT Synthetics and Oral Solids, you will be responsible for the coordination of multiple technical aspects of MSAT and Manufacturing and Supply (M&S) Programs through organization and alignment with other *** group divisions (Commercial Global Business Units, R&D, Regulatory, Alliance Management, etc.), various internal *** support laboratories, and contract CMO facilities. Additionally, as new products approach the registration / launch stage, you will work closely with MSAT CMC Leader, M&S Sites, Supply Chain, CMO's (with External Manufacturing) and Alliance Partners to outline plans and activities.


Key Duties and Responsibilities
• Implements product control strategies
• Provides technical support to manufacturing sites for significant deviations and drives process and product life cycle management improvements for process robustness and yields
• Select appropriate QbD strategies, process parameter risk assessments, application of prior knowledge
• Executes 2nd generation program technical strategies to the MSAT Technical Product Team
• Drafts product- and process specific technical reports to support life-cycle management activities
• Supports MSAT Program Directors and CMC Leaders with planning, coordinating and following activities for the various types of projects outlined above, organizing meetings and preparing project updates for project teams and M&S 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 / CMC Leaders.
• Organizing meetings with project teams for status update and action item follow up to ensure adherence to timelines.
• Organizing meetings with sponsors (R&D, GBU, M&S Teams) to communicate project updates.
• Conducting risk assessments for project activities and outlining contingency plans.
• Creates and maintains detailed project plans with gating / milestones
• Prepares summaries of proposals from CMOs/CROs for projects and presents to management for review.
• Obtains the necessary technical information to support projects at internal *** sites or CMO/CROs.
• Assists with reviewing and finalizing technical documents such as protocols, reports and regulatory dossier content.
• Assists with reviewing contracts (such as CDSs, MSAs, Quality Agreements) and quotations to support CMC development projects, Industrial technical projects and internal Industrial Development programs.


Skills
• 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.


Basic requirements
• At least 7+ 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.
• Open to travel up to ~20% of the time
• Job based in Cambridge, MA, with on-site presence in compliance with *** policy

Job Tags

Contract work,

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