Analyst III, QC Analytical- Limited Term Hire
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I: JOB SUMMARY
This position actively supports routine product in-process, release, and stability testing for the Baltimore (EMOB) site. This includes participation in transfer and implementation of new analytical methods into the EMOB site to support process optimization and manufacturing activities. This may include helping to develop and optimize incoming analytical methods, along with planning and executing verification and validation protocols.
II: ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Routine job responsibilities include, but are not limited to:
• Performs activities involved with transfer of test methods to and from EMOB, including performing method development, optimization, verification, and validation along with writing protocols and reports.
• Provides technical expertise for method development, optimization, verification, qualification and validation.
• Assists with planning and coordinating execution of method transfer activities including ordering of supplies and materials, purchasing equipment, preparation of documents, providing training, coordinating schedules and working with other Emergent sites and collaborators.
• Performs and/or supports investigations and quality change controls as necessary.
• Performs other duties as assigned in support of QC Analytical such as QC testing, equipment maintenance, material intake, and maintaining QC laboratory systems.
• Assists in equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
• Analyzes and formats data to support method evaluation and trending.
• Write SOPs and reports with minimal oversight.
• Evaluation of new technologies or new applications of established technologies that lead to improved product quality and lower costs by supporting process development through improving sample throughput in key analytical methods.
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: MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s degree in Biology, Biochemistry, Chemistry or closely related scientific discipline with 5 years of relevant experience or MS with a minimum of 3 years of relevant experience.
• Skills and knowledge in immunological and ligand-based test methods such as ELISA, Western Blot and SDS-PAGE testing is also desirable.
• Skills and knowledge of general chemical and bioanalytical test methods such as pH, Appearance, UV spectroscopy, TOC, CE, Gel electrophoresis, IEF and qPCR.
• Advanced knowledge of cGMPs, safety and data integrity as relevant to a QC laboratory.
• Experience in executing phase appropriate method qualifications and validations.
• Knowledge of viral based delivery systems and the methods used to analyze them is highly desirable.
• Excellent written and verbal communication skills including ability to write reports for method verification/qualification/validation.
• Experience with LIMS and SAP software applications is desired.•
IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.
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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.