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 mustSAP experienceMust 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.