Bioprocess Associate (Sr., Lead, Supervisor) - Upstream/Downstream

Location
Baltimore (Bayview), MD, US
Posted
Oct 12, 2020
Ref
668180100
Hotbed
BioCapital
Required Education
Bachelors 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.

Bioprocess Associate (Sr., Lead, Supervisor) - Upstream/Downstream

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.

The three levels of Bioprocess Associates (Sr., Lead and Supervisor) operate pharmaceutical equipment and are 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 ( of all levels )
 

  • 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 procedures
  • Troubleshoot, advanced maintenance and repair activities on equipment and systems used in Manufacturing according to Standard Operating Procedures (SOPs)
  • Perform and monitor critical processes, execute routine validation protocols, work orders
  • Informs supervisor/ manager on progress of projects, transfer of data, process details, etc.
  • Executes batch records according to GMP and site quality standards
  • Generates Batch Records, SOPs and Protocols as required
  • Responds to off-hour alarms as assigned by supervisor/ manager
  • Executes manufacturing cleanroom changeover and activation
  • Supports Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
  • Supports Emergent QA during audits and regulatory inspections
  • Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals

 


Sr Bioprocess Associate

Additional Essential Functions

 

 

  • Writes and revises controlled documents
  • Identifies and initiates changes in the control system in partnership with the QA team

 


Required Experience

 

 

 

  • Bachelor's degree in a Scientific, Engineering or Biotech field with 1+ years' experience with biologic production processes under GMP compliance
  • 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

 


Lead Bioprocess Associate

Essential Functions ( In addition to Sr. Essential Functions )

 

 

 

  • Makes decisions in accordance with cGMP standards
  • Collaborates with leadership to ensure sufficient staffing
  • Facilitates meetings

 


Required Experience

 

 

 

  • Bachelor's degree in a Scientific, Engineering or Biotech field with 2+ years' experience with biologic production processes under GMP compliance
  • 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

 


Supervisor

Essential Functions ( In addition to Sr. and Lead Essential Functions )

 

 

 

  • Supervise all manufacturing personnel and activities to ensure the successful time sensitive GMP manufacture and release of products minimal to zero deviations
  • Provides day-to-day oversight of the cleaning contractors; including scheduling activities, overseeing training and providing input regarding personnel changes.
  • Develop and drive execution of a daily schedule
  • Performs and monitors day to day manufacturing operation activities; ensures and verifies compliant execution with cGMP standards and procedures from the cGMP manufacturing areas.

 


Required Experience

 

 

 

  • Bachelor's degree in a Scientific, Engineering or Biotech field with 2+ years' experience with biologic production processes under GMP compliance
  • 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

 


Physical/Mental Requirements (for all levels)

 

 

 

  • 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.