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.

JOB SUMMARY 
The Bioprocess Associate is primarily responsible for the production of bulk vaccines in accordance with cGMP documentation to meet the production schedule and goals of the site as well as cleaning of the GMP areas.  Operations include filter testing, manifold preparation, CIP, SIP, operation of autoclaves and parts washer, production activities and cleaning of the facility when required.  Responsible for operating in a safe and GMP compliant manner, to ensure production goals are met.

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

•    Executes production processes described in the job summary for bulk vaccine manufacturing in accordance with cGMP documentation in the manufacturing area.  Ability to operate manual, semi-automated, and automated equipment in support of routine production under supervision. Operation of autoclave, parts washer, filter integrity tester, manifold preparation, and production activities as needed.
•    Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
•    Informs supervisor/manager on progress of projects, transfer of data, process details, etc.
•    Executes logbooks, forms, solution prep and batch records according to GMP and site quality standards.
•    Revises Batch Records, SOPs and forms as required.
•    Perform cleaning and organize the manufacturing cleanroom. Perform changeover activities.
•    May perform as SME for cleaning the GMP areas. Interacts with the contract cleaning team to complete cleaning. Will be qualified on cleaning processes and techniques.
•    Supports Emergent QA during audits and regulatory inspections.
•    Identifies process deviations, troubleshoots issues immediately, and assists with investigation and potential corrective actions to quality incidents.
•    Supports other manufacturing process teams and cross functional partners 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. 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

•    Bachelor’s degree in a Scientific, Engineering or Biotech field typically with 2+ years’ experience with biologic production processes under GMP compliance or equivalent commensurate experience.  
•    Outstanding knowledge, and ability to apply scientific principles utilized to solve operational challenges, as well as routine production tasks 
•    Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports 

**Evening Shift 2pm- 10:30pm

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.