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Bioprocess Team Lead - 2nd Shift

Employer
Emergent BioSolutions
Location
Baltimore, MD
Start date
Feb 5, 2024

Job Details

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.

  1. JOB SUMMARY

The Lead 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 preparing tubing, equipment, supplies, and other items associated with sterile filling processes as well as routine tasks in the production of drug product for Phase I/II & commercial GMP manufacturing, including setup and operation of equipment and processes associated with sterile filling processes and daily cleaning and sanitization activities throughout the production area. 

This position is 2nd Shift 2PM – 10:30PM

 

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

     

    • Work under general supervision of more experienced Technicians or Manufacturing Supervisor to produce parenteral drugs
    • Comply with cGMP regulations, adhere to EBSI policies, and adhere to EBSI SOP and Batch Record directions.
    • Complete all necessary documentation in a manner that complies with Good Documentation Practices (GDP) as tasks are performed.
    • Independently setup, assemble, and operate all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the sterile core, in accordance with current industry, client and EBSI standards.
    • Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
    • Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
    • Conduct training sessions for less experienced associates to ensure a high level of effectiveness and quality is met during production operations.
    • Responsible for performing bench-top, pilot, scale-up and verification batches.
    • Maintain process equipment according to SOP’s, which may include CIP and SIP of Formulation Tanks.
    • Perform or verify calculations and measurements to ensure that batches made maintain consistent high quality standards.
    • Document activity, as required, in batch records and logbooks.
    • Assist the Technical Transfer Group, Validation, and Engineering departments with the operation and execution of engineering projects. 
    • Interface with the Quality Assurance, Quality Control, Maintenance, and Materials Management departments to resolve production, supply, and equipment issues. 
    • Maintain proper Gowning Qualifications necessary for routine aseptic operations, including filling operations and cleaning.

     

    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 a Scientific, Engineering or Biotech field with 2-3 years’ experience in GMP environment 
    • HS diploma with 7 or more years’ experience in GMP environment 
    • 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, and deviations 

     

     

    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.
     

    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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