Analyst III, QC Analytical
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
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.
• Provides data review to ensure data integrity and adherence to standard operating procedures and cGMP’s.
• Performs other duties as assigned in support of QC Laboratory operations such as QC testing, data reviews, sampling, 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 nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
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.
• Must possess knowledge of and experience with HPLC, GC, cell culture and cell based assays such as TCID50 and plaque assays. 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, Karl Fischer, Moisture Determination, Particle Size, Container-Closure Integrity, 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
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
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.
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.