Lead BioProcess Associate

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.

I: JOB SUMMARY

Responsible for the 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 Production Supervisor to manufacture parenteral drugs
• Perform compounding of pharmaceutical products following Production Batch Record
• Performs and documents developmental formulation batches as required.
• Responsible for performing bench-top, pilot, scale-up and verification batches.
• Edits/writes standard operating procedures as directed by the Production Supervisor
• Review and revise procedures and documentation to ensure cGMP compliance
• Maintains process equipment according to SOP’s, which may include CIP and SIP of Formulation Tanks.
• Performs or verifies calculations and measurements to ensure that batches made maintain consistent high-quality standards.
• Documents activity, as required, in batch records and log sheets.
• Assist the MS & T group, Validation and Engineering staffs 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, SOP’s and Batch Record directions.
• Assist in clean room operations as needed.
• May be called upon to assist in general production activities when necessary.
  
  

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.

III: MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BA/BS in any field
• Or High School/AA with at least three-years of experience in a manufacturing or laboratory setting
  
  

IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.