Project Specialist, MS&T

Location
Rockville, MD, US
Posted
May 29, 2021
Ref
718917300
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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 Specialist will manage the integration of the needs and requirements of the customer, QA, Regulatory, Manufacturing Operations and Engineering. This position will collaborate with multiple departments, subcontractors and external clients to ensure successful technical transfer (process & analytical) of projects by coordinating the execution of procedures, assisting production startup and ensuring adherence to client requirements, CGMPs and quality standards, and safeguarding Emergent's company interests. The Project Specialist will coordinate all activities surrounding the ongoing manufacture of clinical and commercial products including, receipt of client supplied material, document control record generation, sample testing & shipping, product shipping, invoicing and deviation resolution. The Project Specialist will be responsible for generating a training curriculum for Project Management and will continue to integrate PM.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Develop project plans and timelines with input from all required departments. Applies project management best practices in the development, initiation, planning, execution, control and closing of projects.
• Schedule and track project milestones and deliverables using appropriate tools and oversee their successful execution from RFP through technical transfer, batch qualification and product release.
• Anticipate, document, report and mitigate potential project/program risks, road-blocks and changes.
• Clearly communicate project status, issues, and successes. Prepare and deliver presentations of technical information within the department, across functional areas to clients and to senior management concerning project schedules, milestones achieved, mitigation plans for identified delays or risks, changes in project scope and project financials.
• Coordinate technical activities on assigned projects. Responsible for having an awareness of and ability to recognize technical problems.
• Manage and monitor the project budget including: planning, cost/resource implications of the proposed work plans and tracking expenditures.
• Lead cross-functional project team meetings, set and continually manage project expectations with team members and other stakeholders. Delegate tasks and responsibilities to appropriate colleagues, where needed. Provide guidance to cross functional teams to achieve goals in accordance with established policies, cost and schedule guidelines.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Identify and manage project dependencies and critical path. Monitor and manage day-to-day aspects of project and scope, including regular meetings, minutes and reporting with general supervision.
• Host Emergent/Client meetings as required.
• Track and support the authoring of change controls, SOPs, protocols, and reports.
• Requires vaccination against different viruses including Vaccinia virus.

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
• Minimum 2 years of project management experience or 3 years experience in the Pharmaceutical Industry or in a Contract Manufacturing related setting or suitable experience.
• Demonstrated experience building and leading strong cross-functional teams
• Experience in managing drug product, biologics and vaccine development projects including technology transfer is desired
• Excellent written and verbal communication and presentation skills
• Excellent interpersonal skills including negotiating, influencing peers, conflict resolution and active listening
• Must be results oriented, flexible, demonstrate a significant level of initiative and have the ability to comprehend detailed and complex technical, financial and contractual issues.
• Fluent with regularly used software applications (MS Word, MS Excel, MS Project, MS PowerPoint, SharePoint, Visio, Smartsheet)
• Familiarity with Earned Value Management

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.

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