Sr BioProcess Associate
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.
The Senior 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. Operations focus on Downstream Purification activities including unit operations of Cell Disruption, Clarification, TFF, and Formulation. The candidate will also conduct general GMP operations as needed to support activity including equipment assembly, solution preparation, operation of autoclaves, and parts washing. Knowledge and experience of aseptic behavior is a benefit to the candidate. Responsible for operating in a safe and compliant manner, to ensure production goals are met.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Executes production processes for bulk vaccine manufacturing in accordance with cGMP documentation for Downstream Purification activities including unit operations of Cell Disruption, Clarification, TFF, and Formulation
- Ability to operate manual, semi-automated, and automated equipment in support of routine production under supervision
- Ensures all training requirements are completed per the standards set forth by the site
- Maintains a cGMP ready state of production facility. All work is documented compliantly within logbooks and batch records in accordance with good documentation procedures
- Contributes to the quality compliance aspect of the needs of the department in the areas of document revision, deviation report writing and assisting in the execution and implementation of change controls
- Identifies any procedural issue including process deviations, troubleshoots issues immediately, and assists with investigation and potential corrective actions to quality incidents
- Acts as SME or system owner for specific pieces of equipment and procedures. The candidate will assist supporting departments by contributing towards the execution of maintenance, validation, and qualification of equipment and procedures as necessary. 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.
Education, Experience, & Skills
- Bachelor’s Degree in a scientific discipline required. Substitution of Associate’s Degree, Program Certificate, or High School Diploma will be assessed based on additional experience working in a GMP biopharmaceutical/ biotech production environment
- A minimum of 2-4 years of related experience in a GMP biopharmaceutical/ biotech production environment
- Must have a technical understanding of equipment and operations common to executing procedures in support of cGMP FDA licensed manufacturing area
- Must be quality focused with knowledge and understanding of cGMP quality systems and their application to manufacturing operations
- Ability to maintain and operate common laboratory equipment such as pH meters, conductivity meter, filter integrity tester, scales, pumps, and autoclave
- Excellent written and verbal communication skills
- Must be a team player and able to work cross-functionally in a matrixed environment
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.
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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.