Lead Manufacturing Associate

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.

JOB SUMMARY 

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. 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 challenges, as well as routine tasks in the production of bulk drug substance and bulk drug product for 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: autoclaves, parts washers, filter integrity testers, incubators, single use and stainless steel bioreactors, centrifuges, disruptors, TFF skids, single-use mixers and in process testing equipment. Operate in an aseptic manner within a BioSafety Cabinet to perform media fill or cell culture operations using T-Flask and Nunc Cell factories. 
•    Act as the manufacturing SME and qualified trainer for equipment and processes
•    Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures
•    Perform and monitor critical processes, execute routine validation protocols. 
•    Identify and troubleshoot complex events on equipment and systems used in Manufacturing. Initiate deviations per site SOPs. Own Capa/Change Control tasks
•    Informs supervisor/manager on progress of projects, transfer of data, process details, etc.
•    Executes logbooks, forms, solution prep and batch records according to GMP and site quality standards. Perform department review of documentation including BPRs/SPRs 
•    Executes batch records according to GMP and site quality standards
•    Revises Batch Records, SOPs and forms as required. Creates new Batch Records, SOPs and forms
•    Responds to off-hour alarms as assigned by supervisor/ manager 
•    Perform cleaning and organize the manufacturing cleanroom. Perform changeover activities 
•    Supports Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment. Own Change controls for manufacturing equipment and processes
•    Supports Emergent QA during audits and regulatory inspections
•    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. 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

•    Bachelor’s degree in a Scientific, Engineering or Biotech field typically with 6+ years’ experience with biologic production processes under GMP compliance or equivalent commensurate experience.  
•    Outstanding knowledge, and ability to apply scientific principles utilized to solve operational cahllenges, 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.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

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.