Fall River Lead Project Manager

Cipla • Fall River, MA

4d • $100,000 - $125,000 • Onsite

About The Position

The Project Manager position is a highly visible individual contributor role that reports to the Director of Project Management, R D, North America. The job duties for this position include but are not limited to the following: Responsible for end-to-end project leadership and management (scope, cost and time) deliverables for Cipla projects. Operate as the primary liaison and project manager on Internal /external partnerships of Cipla North America. Responsible for delivery on the projects to agreed and planned scope, time, cost and quality. Operate as the single point of contact for Cipla 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 Cipla s version of project plan for all external partnerships. Responsible for drafting and delivering presentations to executive management. In collaboration with Cipla commercial, supply chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness. Responsible for collaborating with Cipla 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 Cipla 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 Cipla 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.
• 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.
• Prior experience in managing projects with internal and/or external stakeholders (e.g., CROs, CDMOs) is a must.
• 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.
• Sitting at a desk and/or working at a computer or other “screen” 75% or greater of an 8-hour period.

Nice To Haves

• Project Management Professional (PMP®) certificate or other relevant project management training is a plus.
• Handling Green field project is plus.

Responsibilities

• Responsible for end-to-end project leadership and management (scope, cost and time) deliverables for Cipla projects.
• Operate as the primary liaison and project manager on Internal /external partnerships of Cipla North America. Responsible for delivery on the projects to agreed and planned scope, time, cost and quality.
• Operate as the single point of contact for Cipla 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 Cipla s version of project plan for all external partnerships. Responsible for drafting and delivering presentations to executive management.
• In collaboration with Cipla commercial, supply chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness.
• Responsible for collaborating with Cipla 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 Cipla 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 Cipla 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.

Benefits

• In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees