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 Senior Scientist will work independently to lead validations and tech transfers for analytical and raw material methods associated with manufacturing processes planned for implementation at the Baltimore site and maintaining methods in a cGMP compliant state throughout their lifecycle. Activities include writing protocols, reports, training and coordinating validation executions cross-funcationally. Common method types include ELISA, Capillary Electrophoresis, and multiple modes of HPLC. The senior scientist will be working directly in the lab and supporting any quality events.

II: Essential Functions

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

• Lead analytical method transfer, optimization, verification, and validation.
• Work directly in the laboratory to establish analytical methods.
• Collect, analyze and interpret data, co-author protocols and reports.
• Demonstrate strong technical writing skills.
• Participating in analytical method investigations.
• Provide scientific review of protocols, reports, study designs, SOPs and test methods.
• Drive the design, development, execution, statistical analysis of validation protocols and reports for analytical, bioanalytical, and compendial methods used for the analysis of biological products and process impurities.
• Collaborate with other functions on a technical level for various projects including but not limited to Quality Control and Manufacturing Sciences & Technology.
• Support quality systems such as change controls and deviations.
• Communicate, support, and meet corporate and site goals and objectives.
• Build and maintain strong relationships within the group, crossfunctionally and with site leads.

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.

III: Education, Experience & Skills

• Bachelors degree in Immunology, Biochemistry, or closely related scientific discipline with at least 10 years of relevant experience, MS with a minimum of 8 years of relevant experience, or Ph.D. with a minimum of 6 years of experience.
• Must possess skills and knowledge within a field such as cellular, immunological, molecular, bioanalytical and chemical test methods; for example, cell culture, ELISAs, qPCR, IEF, viral assays, cell-based assays, SDS-PAGE, Western Blot, microbiological methods, sterility testing, endotoxin testing, HPLC with multiple modes of detecftion, Capilary Electrophoresis, and UV and IR spectroscopy.
• Knowledge of regulatory guidances, cGMPs, safety and data integrity.
• Experience in the following: assay development, optimization, validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products.

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 ourPrivacy 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.