21HC- Project Specialist

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.

PROJECT SPECIALIST

Under the direction of the MSAT Director, the project specialist position will create and manage complex technical projects supporting process development, continuous improvement/efficiency, deviations, CAPAs, and change controls. The position will manage projects ensuring milestones, requirements, and escalation/communication are identified and resolved as required to accomplish department, site, and corporate goals. The ability to provide hands execution in some cases will be required (set up and operation of systems, utilizing plant automation systems to obtain data). These activities will require a detailed understanding of not only the unit operations required to successfully produce product but quality principles and procedures. They will also support Manufacturing Technology quality systems (deviations, CAPAs, and change controls), collect and analyze data, write and revise procedures and protocols, collaborate with other departments on commissioning and qualification activities, use GDP and GLP, and have an interest in further developing operational skills to perform a variety of activities.

Essential Functions

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

Under the direction of the MSAT Director, the project specialist will:
• Create and implement project plans
• Proactively identify, assess, and appropriately manage risks
• Apply project management best practices through the execution of all project phases to include supporting the acquisition of new process systems
• Manage data as required in support of organization projects and standards. This will include statistical treatment and interpretation.
• Support both existing and new site mission and objectives to include ACAM2000® smallpox vaccine production and CDMO related activities
• Support site QA during audits and regulatory inspections
• Collaborating with Engineering, Facilities, CQV (Commissioning, Qualification, and Validation), Manufacturing, and vendors for commissioning and qualification of new/upgraded pilot equipment
• Write and revise project plans, protocols, reports, and other documents as required
• Maintain qualifications for site training requirements and demonstrate quality and safety for all operational activities.
• Support manufacturing, engineering, validation, quality process teams at the site and corporation to achieve goals. This may include travel to other EBSI sites.

Minimum Education, Experience, Skills
Requirements
• BS in Bioengineering, Biology or related field and/or a minimum 1-3 years related industrial experience
• Knowledge and experience in biologics development and CGMP manufacturing for biologics and vaccines
• Mechanical aptitude and experience with the equipment lifecycle (Design qualification, URS, Fabrication, FAT/SAT through commissioning
• Experience with Adeno-associated viral vector production and purification
• Knowledge of the principles of statistical analysis, data interpretation and management
• Technical writing - the ability to create concise and complete documents
• A knowledge of the principles of operational excellence is desirable
• Basic skills and fluency in Microsoft Word, Excel, PowerPoint, and Project

Skills
• Strong interpersonal, time management, laboratory, and computer skills
• Science based approach and commitment to integrity
• Demonstrates success in commitment, accountability, and technical proficiency
• Creative, critical thinking and collaboration skills with diverse groups with others
• Decision making and exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ensures cross-functional alignment and communication of issues and strategies.

Interested? Please visit emergentbiosolutions.com and apply under the career section today!

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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