Sr Bioprocess Associate

Location
Rockville, MD
Posted
Apr 25, 2022
Ref
864852200
Hotbed
BioCapital
Required Education
High School or equivalent
Position Type
Full time


 

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.

I.    JOB SUMMARY 
The primary role of this position is to provide technical support for all fill-finish and packaging operations in the CDMO environment with strict adherence to cGMP compliance. This position requires proficiency in aseptic technique, buffer formulation using disposable mixing tanks, Integrity testing of various filters. The candidate for this position will be working in close association with Technical Operations, Quality Assurance, Quality Control, and Material Management to overcome challenges in meeting the production schedule.

 

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

•    Execute daily tasks in support of filling and packaging Ops.
•    Operate Filter integrity devices to confirm the integrity of filters pre and post use.
•    Buffer formulation using disposable mixers and sterile filtration.
•    Biosafety cabinet cleaning and operation using aseptic techniques. 
•    Perform Aseptic filling operations and dynamic monitoring/sampling inside various isolators.
•    Assist with Safety and Quality investigations, utilizing Root Cause Assessment techniques, and CAPA identification.
•    Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and Generates Purchase requisitions for consumables items within the MFG department.
•    Assist in activities related to cross-functional departments such as the execution of validation protocols.
•    Comply with all applicable health, safety and environmental policies promoting a safe workplace to prevent or reduce injuries.
•    Perform tasks under minimal supervision, and within tight timelines to meet production schedule.
•    Report any unexpected observations and suggest possible explanation and resolution
•    current Good Manufacturing Practices (cGMP).
•    Author and revise batch records and SOPs.
•    Train junior staff and act as process and equipment SME.
•    Perform routine reviews on executed batch records and logbooks.
•    Initiate deviations, CAPAs, and Change Controls.

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
•    BS/BA degree preferred. Associates degree and/or High School Diploma acceptable with experience.
•    3-4 years of experience with Bachelors
•    5-6 years of experience with Associates
•    7+ years with High School Diploma
•    Good interpersonal skills and attention to detail.
•    Analytical, organized, self-motivated, and good at multi-tasking.
•    Previous experience with CDMO
•    Previous experience working with aseptic technique and good documentation practices is required.
•    Must be able to follow cGMP regulations during operations including adherence to written procedure and contemporaneous documentation.
•    Must be able to communicate effectively with management and staff.
•    Must be able to record data accurately and legibly.
•    Demonstrated mechanical aptitude and have manual dexterity. 
•    Ability to perform in a team setting in a controlled environment for long periods of time.

 

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.
 

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.