Nesco Resource
Overview
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 are not 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 the 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 products is 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 a 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. Seniority level
Associate Employment type
Full-time Job function
Project Management Industries: Pharmaceutical Manufacturing
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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 are not 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 the 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 products is 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 a 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. Seniority level
Associate Employment type
Full-time Job function
Project Management Industries: Pharmaceutical Manufacturing
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