25 days old

Lead BioProcess Associate

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.

I.             JOB SUMMARY

 

The Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing.  Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. This role is responsible for manufacture of biopharmaceuticals, including bench top, scale up and pilot formulations; preparing and operating process equipment, handling materials, dispensing chemicals and interfacing with Maintenance, QA, QC and Tech Group in a cGMP environment.

 

II.            ESSENTIAL FUNCTIONS

 

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

 

  • Work under general supervision of Manufacturing Supervisor to produce parenteral drugs
  • Perform compounding of pharmaceutical products following Production Batch Record.
  • Perform and document developmental formulation batches as required.
  • Responsible for performing bench-top, pilot, scale-up and verification batches.
  • Maintain process equipment according to SOPs, 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. 
  • Assist with the preparation of materials needed for Formulation.
  • Comply with cGMP regulations; adhere to EBSI policies, SOPs and Batch Record directions.

 

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

 

  • High School diploma with 4 years experience in a cGMP environment is required.
  • Certificate or Associates Degree in Biology, Chemistry or Biochemistry with 1 year experience is preferred. Experience working in a federally regulated cGMP environment is a plus. The ability to work cross-functionally with multiple departments and excellent oral and written communication skills are required.
  • 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, SOPs, deviation & summary reports

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.

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Posted: 2020-12-31 Expires: 2021-02-07

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Lead BioProcess Associate

Emergent BioSolutions Inc.
Baltimore, MD 21202

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