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Sr BioProcess Associate - Upstream

Employer
Emergent BioSolutions
Location
Baltimore (Bayview), MD
Start date
Nov 19, 2021

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Job Details


 

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.

  1. JOB SUMMARY
The Senior Bioprocess Associate position reports to Supervisor/Manager Manufacturing.  Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. This role is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing. 

 

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

     

      Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures Perform and monitor critical processes, execute routine validation protocols, work orders and repairs Informs supervisor/ manager on progress of projects, transfer of data, process details, etc. Executes batch records according to GMP and site quality standards Generates Batch Records, SOPs and Protocols as required Responds to off-hour alarms as assigned by supervisor/ manager Executes manufacturing cleanroom changeover and activation Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment Supports Emergent QA during audits and regulatory inspections Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals

     

     

    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

     

      HS diploma with 5 or more years’ experience with production processes under GMP compliance OR  Associate degree in a Scientific, Engineering or Biotech field with 2-4 years’ experience with or biologic production processes under GMP compliance OR  Bachelor’s degree in a Scientific, Engineering or Biotech field with 1-3 years’ experience with biologic production processes under GMP compliance  Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks  Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports 

     

    Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

     

    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.

    Company

    Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

    Stock Symbol: EBS

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    Company info
    Website
    Phone
    240-631-3200
    Location
    400 Professional Drive
    Suite 400
    Gaithersburg
    Maryland
    20879
    United States

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