Term - Specialist, MS&T

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary - THIS IS A TERM POSITION

The Specialist, MS&T role is a member of the Manufacturing Sciences & Technology (MS&T) department providing technical expertise to support Production (manufacturing, aseptic filling, and packaging departments). It also includes the support of internal / external Technology Transfers of new products/processes for both clients and Emergent. The role includes participating in troubleshooting, investigations, reviewing deviations, executing corrective and preventative actions (CAPAs), data trending, protocol and report generation, and batch record authoring/editing to support the successful manufacture of commercial products

Responsibilities
• Supports the Transfer of new processes into the manufacturing site for subsequent qualification and validation for potential commercialization
• Supports the evaluation and transfer of process development recommendations into operations.
• Participates in cross-functional brainstorming sessions to direct the flow of information and ensure all avenues are explored
• Provides subsequent troubleshooting, investigations, data review and analysis, execution of CAPAs, etc. on commercialized processes
• Identifies, recommends, and implements improvements to equipment, techniques, materials, and processes.
• Authors batch record and standard operating procedure creation and changes.
• Conducts statistical process control by supporting routine data trending and root cause analysis.
• Acts as a subject matter expert (SME) for quality investigations of process related deviations.
• Participates in Gemba walks by identifying, recommending, and implementing improvements to equipment, techniques, materials, and processes as required.
• Supports qualification activities and studies associated with continuous improvements projects. This could include generation of protocols and reports, assessment of data, and protocol execution.
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.

Education, Experience & Skills
• Bachelor’s degree in science, Engineering or related field is strongly preferred; an equivalent level of education, skills, and experience will be considered.
• Extensive Knowledge of cGMP and process validation along with expertise in manufacturing processes and design, supporting technology transfer.
• 10+ years of experience in pharmaceutical manufacturing / process engineering or related field including operations support and troubleshooting.
• Demonstrated ability to conduct problem solving and analysis of data to derive conclusions and deliver guidance.
• Strong technical writing and oral communication skills and knowledge of Microsoft Office Suite of Products.
• Ability to work independently, while maintaining positive, collaborative relationships cross-functionally.

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.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. 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.