Lead BioProcess Associate Upstream
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 Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. The Lead BPA is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.
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.
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
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
- 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.
- Minimal travel to other sites.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.