Project Manager - Technical Services

Job Title:      Project Manager, Technical Services

Location:      Columbus, OH

Job Type:     Full time

Req ID:         10913

 

About Us: 

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Project Manager, Technical Services to join our team.  

In this role, you will be responsible for leading and managing 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.

 

Key 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, producti