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Posted in Engineering 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Baltimore, Maryland

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: Job Summary

The Project Manager has total responsibility and accountability for the integration of the needs and requirements of the customer, QA, Regulatory, Manufacturing Operations and Engineering. The Project Manager leads the technical transfer of products by coordinating the execution of the transfer procedures, assisting production startup by communicating and negotiating client requirements, ensuring adherence to CGMPs and quality standards, and safeguarding Emergent’s company interests. The Project Manager coordinates all activities surrounding the ongoing manufacture of clinical and commercial products including, receipt of client supplied material, production control record generation, sample shipping, product shipping, invoicing and non-conformance resolution.


II: Responsibilities

    • Ensure the dissemination of the client requirements related to the approved quote or supplier agreement within Emergent BioSolutions, assigning and coordinating the tasks related to the introduction of new processes/projects within the site.

    • Coordination and control of the project progress, including: continuous contact with clients, identification and troubleshooting of technical problems, managing the project team until the problems are resolved, production and QC assistance in the project introduction initial phases, i.e.: analytical transfer, installation feasibility studies, trials, batch validation.

    • Develop project plans and timelines with input from all required departments. Schedule and track project milestones and deliverables using appropriate tools. Anticipate potential project/program road blocks.

  • Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders. Proactively manage changes in project scope and prepare change orders promptly for tasks outside the project scope. Establish performance standards and goals for projects including determining individual processes for meeting established goals.

    • Responsible for the project budget, including: planning, cost/resource implications of the proposed work plans and tracking expenditures.

    • Identify and manage project dependencies and critical path.

  • Lead project team meetings. Set and continually manage project expectations with team members and other stakeholders. Where needed delegate tasks and responsibilities to appropriate personnel. Provide guidance to cross functional teams to achieve goals in accordance with established policies, cost and schedule guidelines.

    • Host Emergent/Client meetings as required.

    • Collect deliverables as required for the project and ensure they meet regulatory requirements. Ensure that all necessary project documentation is completed accurately, timely and in compliance with requirements.

    • Identify and resolve issues and conflicts with/within the project team.

    • Lead continuous improvement efforts for clinical and commercial products.

    • Establish and recommend changes to procedures which affect the Corporate Unit, site or Department or area of responsibility.

    • Work on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Erroneous decisions or failure to achieve goals results in additional costs and serious delays in overall schedules.

    • Work independently. Meet with Director to review and measure performance based on meeting objectives and schedules.

    • Frequently interacts with Director, internal customers and external contacts and/or other functional peer group managers and senior management.

    • Prepare and conduct presentations of technical information within the department, across functional areas to clients, and to senior management concerning specific projects/schedules.

Supervisory Responsibilities:

Directly responsible for leading project teams consisting of other managers, supervisors and senior support staff in order to push products from introduction to manufacturing and commercialization. Responsible for the P&L for each project. Each project manager holds a client portfolio with oversight of ~20-30% of the revenue and associated profit for the site.

Responsible for managing all aspects of the relationships with existing customers.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

  •        Bachelor’s degree in science, engineering or business; MBA highly desirable

    • And/or a minimum of 5 years experience in Project Management in the Pharmaceutical Industry or in a Contract Manufacturing related setting or suitable experience.

    • Proficient in MS Project preferred

IV: Physical/Mental Requirements

Type/keyboard, visual acuity, stand, walk, sit,. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.




Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.