Senior Project Manager

• Executes 2nd generation program technical strategies to the MSAT Technical Product Team, focused on pharmaceutical development of oral dosage forms for small molecules.
• 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, and application of prior knowledge.
• 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.
• 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 them 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.

• BS/MS in chemistry, pharmacy or science with strong experience in Pharmaceutical development, specifically oral dosage form for small molecules, 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 7+ years' experience in technical project management, relevant pharmaceutical development, technical operations and/or manufacturing of various drug product dosage forms for small molecules.
• Must have prior experience as a project manager of technical projects with demonstrated ability to facilitate multi-disciplined teams.
• Experience with international project teams is a plus.
• Quality and/or Regulatory background is also highly desirable.
• Open to travel up to ~20% of the time.

Cynet Systems