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.
I. JOB SUMMARY
The Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing. Prior experience in GMP manufacturing and operation of GMP process equipment are prerequisites. This role is responsible for manufacture of biopharmaceuticals, including bench top, scale up and pilot formulations; preparing and operating process equipment, handling materials, dispensing chemicals and interfacing with Maintenance, QA, QC and Tech Group in a cGMP environment.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Work under general supervision of Manufacturing Supervisor to produce parenteral drugs
• Perform compounding of pharmaceutical products following Production Batch Record.
• Perform and document developmental formulation batches as required.
• Responsible for performing bench-top, pilot, scale-up and verification batches.
• Maintain process equipment according to SOP’s, which may include CIP and SIP of Formulation Tanks.
• Perform or verify calculations and measurements to ensure that batches made maintain consistent high quality standards.
• Document activity, as required, in batch records and logbooks.
• Assist the Technical Transfer Group, Validation, and Engineering departments with the operation and execution of engineering projects.
• Interface with the Quality Assurance, Quality Control, Maintenance, and Materials Management departments to resolve production, supply, and equipment issues.
• Assist with the preparation of materials needed for Formulation.
• Comply with cGMP regulations; adhere to EBSI policies, SOP’s and Batch Record directions.
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
• High School diploma with 4 years experience in a cGMP environment is required.
• Certificate or Associates Degree in Biology, Chemistry or Biochemistry with 1 year experience is preferred. Experience working in a federally regulated cGMP environment is a plus. The ability to work cross-functionally with multiple departments and excellent oral and written communication skills are required.
• 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
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.
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.