Project Manager - Technical Services

Project Manager, Technical Services

Overview

Project Manager, Technical Services will lead and manage cross-functional project teams for products produced or distributed from Hikma Generics - Columbus either via launch, transfer and/or lifecycle.

This position is responsible to provide all necessary project management skills/tools for the successful, timely completion of all assigned projects in order to achieve the site’s goals for each year with key performance indicators being timing, cost and process robustness.

This role has full accountability for the planning and execution of Generic commercialization, Site Transfers, Buy-ins, Third Party, Alternate API, process changes (Quality & Product Robustness driven) and changes to Active Pharmaceutical Ingredients, Excipient, Packaging and Raw Material items.

Responsibilities

Manages and delivers organizational and project leadership for Generic commercialization, Site Transfers, Buy-ins, Third Party, Alternate API, process changes (Quality & Product Robustness driven) and changes to Active Pharmaceutical Ingredients, Excipient, Packaging and Raw Material items.

Proactively identifies & manages risk which could adversely affect successful project completion.

Lead & facilitate multiple cross-functional team by managing and directing project team resources / experts to identify relevant issues and effectively manage progress and change.

Ensures integration of technical/commercial information and activities necessary to develop and support the success of the plan by utilizing project management skills/tools, including but not limited to, to successfully drive the project to meet established timelines:

• Project Plan
• Meeting Minutes/Agendas
• RAID log
• Costing assessments
• Meeting facilitation (Core & relevant sub-teams)

Assesses critical data and contributes information to identify / facilitate critical “Go / No Go” project decisions. Provide proactive communication to all stakeholders, regarding issues, risks, contingency plans and potential negative impacts to the established milestones and timelines.

Lifecycle Project Managers ensure change management requirements are being facilitated i.e.

• Initial change notification assessment (SME assessment, cost evaluation, Master Change assessment)
• Management of Tactical and Strategic change meetings
• Creation of required Protocols (Change & Master Change)
• Creation of Qualification Technical Reports
• Management of CC’s in appropriate system
• Stage/Que/Monitor work in-progress
• Develop/Manage implementation plan
• Ensure Document review prior to final implementation

Assess completed projects for lessons learned to drive improvement in project performance/execution and capture data to drive/refine resource allocation/costing for future projects

Skills

Proficient knowledge and understanding of applicable regulations pertaining to the development and manufacturing of pharmaceuticals including cGMP, DEA, and FDA, EMEA.

• Must possess knowledge of SOP’s, production processes and equipment and have thorough understanding of pharmaceutical supply chain operations, business analysis, and pharmaceutical technology. In addition, demonstrated knowledge of pharmaceutical development, scale-up and validation, and lifecycle processes.

• Proficient knowledge and understanding of project management methodology with an active PMP certification with the ability to effectively manage and partner with subordinates, peers, suppliers and contractors.
• Demonstrated ability to deliver on results to meet determined business objectives/targets.
• Demonstrated ability to communicate effectively (oral and written) both internally and externally at various levels locally, regionally & globally
• Demonstrated knowledge in continuous improvement methodologies and implementation with an active six-sigma certification preferred.

 

Competencies:

• Critical Thinking: Ability to work in uncharted areas; capable of integrating large amounts of information to address complex issues.  Challenges conventional wisdom when required.  Intellectually aggressive with a strong end-product orientation.

• Problem Solving: Proficient knowledge and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level.  Uses problem solving abilities requiring attention to detail, accuracy, and scientific judgment.  Develops solutions to a variety of problems of high scope and complexity.

• Project Management: Experience managing and leading projects and/or process improvements teams of high scope and complexit