13 days old

Analyst III, QC Biochemistry

Emergent BioSolutions Inc.
Baltimore, MD 21202


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 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.

 

ESSENTIAL FUNCTIONS

Perform 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 cGMPs

Performs other duties as assigned in support of Quality Control Laboratory operations such as Quality Control testing, data reviews, sampling, and maintaining Quality Control 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 throughout 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 managements assignment of essential functions.

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Bachelors Degree in Biology, Biochemistry, Chemistry, or closely related scientific discipline with 5 years of relevant experience; Masters Degree 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 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 Quality Control 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 application 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 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 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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Posted: 2021-01-07 Expires: 2021-02-10

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Analyst III, QC Biochemistry

Emergent BioSolutions Inc.
Baltimore, MD 21202

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