Sr. Project Manager - R&D

Sr. Project Manager – R&D

Bedford, OH

 

Overview

 

Plan, organize, monitor, facilitate, and drive technical Research & Development (R&D) programs for injectable pharmaceutical products by utilizing technical and pharmaceutical knowledge.

 

Responsibilities

 

Oversee budgets, timelines and priorities for pharmaceutical R&D projects. Manage pharmaceutical R&D projects by planning, monitoring, and facilitating projects and developing project scope, timelines, project estimates, and resource requirements in collaboration with the cross-functional teams as well as external partners. Prepare and manage the project risk register for making decisions regarding the appropriate risk when there is substantial project impact. Operate within Hikma’s Global network of R&D departments by working simultaneously with multiple Hikma sites and R&D, Site Technical Services, Regulatory Affairs, Marketing, and other stakeholders (including strategic partners) to ensure that all needed activities are identified and integrated into a comprehensive plan for pharmaceutical R&D projects. Negotiate with the internal and external stakeholders on deliverables and hold team members accountable to agreed-upon timelines for the deliverables. Work with external partners on complex injectable products to drive timely completion of the development activities as well as timely submission of the Electronic Common Technical Document file to the FDA. Lead cross-functional pharmaceutical project teams to adhere to key project timeline milestones, risk management analysis, key transfer dates, and overall project and business goals. Identify critical paths and barriers. Deliver implementation strategies and resolve issues impacting them. Proactively manage projects, anticipating issues, and potential delays to achieve on-time completion. Organize and lead regular project review meetings with cross-functional departments. Issue meeting minutes and capture decisions and action items. Escalate issues/critical events and facilitate prompt attention/resolution. Identify creative solutions using past experience and training. Provide input to pharmaceutical R&D project prioritization process. Resolve technical challenges with the Active Pharmaceutical Ingredient (“API”) suppliers, internal team members, as well as 3rd party labs and external partners using project management tools and processes. Constantly use the Hikma SPOT system and Wrike to input accurate and timely updates that are used to publish reports to managements (e.g., API timelines, submission batches, stability-in date, submission date, and other deliverables and milestones).

 

Qualifications

 

Must have a bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology or a related science field, or the equivalent and five years of progressive post-baccalaureate cross-functional project management experience with a focus on injectable pharmaceutical products.

 

Those interested in this position, send CV to columbusrecruiting@hikma.com (ID: 5654).