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. The role of the Senior Scientist requires advanced knowledge and understanding of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment. This position will also serve as a subject matter expert (SME) across one or more core functions/scientific disciplines, both within the department and across the site/company. Primary responsibilities include scientific and technical leadership on projects and initiatives, preparation and execution of studies, and data analysis and interpretation to support development and manufacturing activities. Another responsibility is to coordinate with the teams in the preparation and conduct of study protocols, data analysis, reports and standard operating procedures (SOPs) that support development and manufacturing activities. Responsibilities include preparation of GMP validation protocols, reports and conducting validation of manufacturing processes and test methods. Additional responsibilities include validation and technology transfer of both manufacturing processes and test methods. Additional responsibilities include coordination with management staff on projects and initiatives. Responsibilities * Technical lead/support for quality system responsibilities (process-related investigations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, etc.)
* Serve as lead study owner for studies and reports relating to process understanding, characterization, validation, and QbD.
* Serve as expert reviewer for studies, reports, project plans, regulatory submissions, and other documents relating to process understanding, characterization, and validation
* Participate as technical expert in site regulatory inspections as needed
* Generate Intellectual Property (IP) as process owner
* Develop project plans including work scope, timeline, and cost estimates for process improvements, process development, and capital projects
* Present data/project updates to management and inter-departmental teams
* Leverage technical expertise across sites and/or programs
* Provide technical leadership, mentoring, and coaching to departmental and site staff
* Serve in a leadership capacity on cross-functional, departmental, and site-wide teams
* Provide technical expertise in one or more of the key areas, such as manufacturing upstream, downstream, fill/finish, BiaCore, Total Protein content, SDS-PAGE, Western blot, PCR, cell based assays, potency assays, ELISA, and various other analytical methods.
* Provide technical expertise in one or more of the key areas, such as process design and validation; technology transfer and understanding of fill finish activities. Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, lift/carry 50lbs, and pull 50lbs. Use phone, copier, computer, copier, and hand tools. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem-solve, make decisions, plan, communicate, prepare written communications, and prepare transaction documents. Work around noise above conversation level, in multiple locations, and with restricted access laboratory. 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.
Employer's Job# 627690100
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