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Pharmaceutical Project Manager

Pharmaceutical Project Manager

Nesco ResourceFall River, MA, United States
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A major client of ours in the Fall River, MA area, has a need for a Project Manager. This is a full-time onsite position.

Responsibilities

  • Responsible for end-to-end project leadership and management (scope, cost and time) deliverables for Company projects.
  • Operate as the primary liaison and project manager on Internal / external partnerships Responsible for delivery on the projects to agreed and planned scope, time, cost and quality.
  • Operate as the single point of contact for Company internal stakeholders on all aspects of projects. Internal stakeholders include but limited to executive management committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs, regulatory affairs, quality assurance, procurement etc.
  • Act as the custodian of the project governance process. Responsible for stage-gate reviews and escalation of topics, as required. Responsible for maintaining a Company version of project plan for all external partnerships. Responsible for drafting and delivering presentations to executive management.
  • In collaboration with commercial, supply chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness.
  • Responsible for collaborating with Company global stakeholders particularly Integrated Product Development (IPD) and Quality Assurance (QA) to incorporate technical best practices including QbD principles in all technical studies.
  • Participate and / or lead technical due diligences on projects where Company is actively engaged with a potential partner to in-license or co-develop a product.
  • Maintain a pro-active, informed and nimble approach for all aspects that may affect the delivery of the projects to approved plan.
  • Maintaining strategic alignment between the program, organization and stakeholders
  • Provide relevant feedback to Company commercial and portfolio functions on assumptions, risks and market developments leading to development of commercial models.
  • Lead and implement a risk-based approach towards assessment of projects, project milestones and stage gate reviews.
  • Lead and / or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to relevant stakeholders.
  • Maintain effective and pro-active communication and coordination of activities with multi-functional internal and external stakeholders.

Requirements

  • Masters in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry, Medicinal Chemistry or Chemical Engineering.
  • Project Management Professional (PMP®) certificate or other relevant project management training is a plus.
  • Experience with product development process as applied to 505(b)(1) NDA and / or 505(b)(2) NDA and / or BLA product registration pathways is a must.
  • Experience in handling complex injectable and Inhalation a plus.
  • Prior experience in managing projects with internal and / or external stakeholders (e.g., CROs, CDMOs) is a must.
  • Handling Green field project is plus.
  • Experience with project governance practices is a must
  • SAP experience
  • Must be proficient in applicable computer and database applications including MS Word, MS Excel, PowerPoint, and PDF.
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.
  • Demonstrable acceptable skills in oral and written communications, independent judgement, problem solving and effective managing and adhering to timelines.
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    Project Manager • Fall River, MA, United States

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