14 days ago
Emergent BioSolutions (NYSE: EBS), headquartered in Gaithersburg, Maryland, is a global life sciences company that provides a diverse portfolio of specialty products and services that address public health threats. The company develops, manufactures, and commercializes medical countermeasures (MCM) against chemical and biological, (CBRN) threats, as well as explosive-related threats and existing and emerging infectious diseases (EID). In 2018, the company diversified the scope of its public health threat mandate significantly by acquiring Adapt Pharma, the maker of NARCAN® Nasal Spray for opioid overdose reversal, and PaxVax, the maker of Vivotif® and Vaxchora®, which are marketed travelers vaccines for typhoid and cholera, as well as a number of R&D programs at various stages of development.
Emergent BioSolutions continues to drive innovation and achieve significant growth YOY—growing from a company with only one product and less than $300M in revenue in 2012 to a broader base with 10 products that are now marketed or procured globally. The company is on target to exceed $1B revenues for 2019, one year ahead of plan, while advancing the founding mission to protect and enhance life. The company operates through four business units:
* CONTRACT DEVELOPMENT & MANUFACTURING
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
The Senior Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites.This role 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.
* ESSENTIAL FUNCTIONS
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 proceduresPerform and monitor critical processes, execute routine validation protocols, work orders and repairsInforms supervisor/ manager on progress of projects, transfer of data, process details, etc.Executes batch records according to GMP and site quality standardsGenerates Batch Records, SOPs and Protocols as requiredResponds to off-hour alarms as assigned by supervisor/ manager Executes manufacturing cleanroom changeover and activationSupports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipmentSupports Emergent QA during audits and regulatory inspectionsSupports 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 5 or more years' experience with production processes under GMP compliance ORAssociate degree in a Scientific, Engineering or Biotech field with 2-4 years' experience with or biologic production processes under GMP compliance ORBachelor's degree in a Scientific, Engineering or Biotech field with 1-3 years' experience with biologic production processes under GMP complianceOutstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasksExcellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
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.
Emergent's mission is simple—to protect and enhance life.
As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.
1,500 to 1,999 employees