Analyst II, QC

Location
Baltimore (Bayview), MD, US
Posted
Oct 28, 2020
Ref
657524000
Discipline
Quality, Quality Control
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

JOB SUMMARY

This position actively supports routine product 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. This position supports the second shift operations at the Bayview manufacturing site.

ESSENTIAL FUNCTIONS
  • 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 investigations when 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 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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • Bachelor's degree in Biology, Biochemistry, Chemistry or closely related scientific discipline with 3-5 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. Skill and knowledge in immunological test methods such as ELISA and Western Blot testing is also desirable.
  • Skills and knowledge of general chemical and bioanalytical test methods such as Karl Fischer, Moisture Determination, Particle Size, Container-Closure Integrity, CE, Gel electrophoresis, IEF, PCR, and UV spectroscopy.
  • 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 is desired.


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

  • 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 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.

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