Lead 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.
- JOB SUMMARY
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Operates pharmaceutical manufacturing equipment such as: incubators, wave reactors, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers and in process testing equipment
Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures
Troubleshoot, advanced maintenance and repair activities on equipment and systems used in Manufacturing according to Standard Operating Procedures (SOPs)
Perform and monitor critical processes, execute routine validation protocols, work orders
Informs supervisor/ manager on progress of projects, transfer of data, process details, etc.
Executes batch records according to GMP and site quality standards
Generates Batch Records, SOPs and Protocols as required
Responds to off-hour alarms as assigned by supervisor/ manager
Executes manufacturing cleanroom changeover and activation
Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
Supports Emergent QA during audits and regulatory inspections
Supports other manufacturing process teams and other EMOB groups 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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
HS diploma with 7 or more years’ experience with production processes under GMP compliance OR
Associate degree in a Scientific, Engineering or Biotech field with 5 years’ experience with or biologic production processes under GMP compliance OR
Bachelor’s degree in a Scientific, Engineering or Biotech field with 2-3 years’ experience with biologic production processes under GMP compliance
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, deviation & summary reports
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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.