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Project Manager, MS&T

Employer
Emergent BioSolutions
Location
Rockville, MD
Start date
Sep 25, 2022

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Discipline
Clinical, Clinical Project Management
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital
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Job Details

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.

  1. 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 record generation, sample shipping, product shipping, invoicing and non-conformance resolution.

 

 

  • ESSENTIAL FUNCTIONS
  • Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

     

    • Develop and maintain project plan documents including Technical Baseline, Risk Management Plan and Gantt charts to track and report project status. Identify, report, and document changes to the project.
    • Build and lead cross-functional project teams to implement the project plan to achieve project deliverables, timelines, schedules and budgets. Lead technical transfers to onboard new clients and products.
    • Manage the contractual, technical and financial requirements of each project with general instructions.
    • Monitor and manage day-to-day aspects of project and scope, including regular meetings, minutes and reporting with general supervision to ensure schedule adherence. 
    • Identify and manage project dependencies and critical path. Manage projects to completion on time in full and remediate roadblocks that impact adherence to schedule.
    • Review and evaluate deliverables prepared by the project team, lead communication and delivery to the sponsor/client and resolve difficult problems to complete deliverables.
    • Develop and deliver engaging, informative and well-organized presentations. Provide regular updates and recommendations on the project status, including milestones achieved, mitigation plans for identified delays or risks, and changes in project scope and project financials.
    • 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, etc.

     

     

    The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

     

    III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

    • Bachelor’s degree in science, engineering or business; MBA highly desirable
    • Minimum 3 years of project management experience or 5 years experience in the Pharmaceutical Industry, in a Contract Manufacturing related setting or suitable experience
    • Demonstrated experience building and leading strong cross-functional teams
    • Experience in managing drug (small molecule), biologic, and vaccine development projects
    • including technology transfer is desired
    • Excellent written and verbal communication skills
    • Excellent interpersonal skills including negotiating, influencing, and active listening
    • Fluent with regularly used software applications (MS Word, MS Excel, MS Project, MS
    • PowerPoint, SharePoint, Visio)
    • Familiarity with Earned Value Management
    • Familiarity with FDA cGMP and FDA regulations relating to biologic and drug products
    • Working knowledge of SAP

     

     

     

    Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

     

    There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

    Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
     

    Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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.

    Company

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

    Stock Symbol: EBS

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    Find Us
    Website
    Phone
    240-631-3200
    Location
    400 Professional Drive
    Suite 400
    Gaithersburg
    Maryland
    20879
    United States
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