BioProcess Specialist

Location
Baltimore (Bayview), MD, US
Posted
Apr 29, 2021
Ref
738162300
Hotbed
BioCapital
Required Education
Associate Degree
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 ( 2-4 sentence description of overall job purpose)

The Bioprocess Specialist position reports to Supervisor/Manager Manufacturing at Emergent Manufacturing Operations Baltimore (EMOB). Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites. This position will collaborate with manufacturing development, functional managers and manufacturing associates in executing various manufacturing processes using multiple manufacturing platforms.

II: Essential Functions
  • Operates pharmaceutical manufacturing equipment such as: incubators, single-use bioreactors.
  • Assists in identifying, planning and implementation of innovative technological programs and solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost effective manner.
  • Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
  • Interfaces, schedules and performs on-site monitoring of outside services of all manufacturing equipment.
  • Acts as qualified trainer for pharmaceutical manufacturing equipment.
  • Ensures all safety and compliance procedures are followed at all times.
  • Assists with investigations and problem resolution and provides clear and concise communication to supervisor/management.
  • Executes projects with minimal instruction and management oversight.
  • Assists manufacturing development for tech transfer activities and process design.
  • Executes batch records according to GMP and site quality standards.
  • Writes and revises controlled documentation (SOP's, Forms, Technical Reports, Batch Records, Protocols, etc.)
  • Responds to off-hour alarms as assigned by the Manager Manufacturing
  • Executes manufacturing cleanroom changeover and activation
  • Assists Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment


The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

I: Job Requirements
  • Bachelor degree in relevant field required or sufficient scientific and technical depth has been achieved from professional experience.
  • Minimum 5 years of GMP pharmaceutical experience
  • Expert knowledge of the installation, operation, cleaning and maintenance of pharmaceutical manufacturing equipment
  • Knowledgeable of application and practices of current GMP's, international regulatory requirements and guidelines.
  • Computer literate (Word, Excel and PowerPoint)


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.

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