Bioprocess Engineer (Downstream)

Columbia, MD
Full Time
Mid Level

Working with an excellent organization in the Greater Washington/Baltimore area who is looking to bring on well versed and educated Bioprocess Manufacturing Engineers.

 

Responsibilities:
Act as a primary technical point of contact within the organization, supporting biologics processes and technical transfer activities.

 

  • Ensure that robust, scalable, commercially-viable processes are accurately developed.
  • Lead process tech transfer activities required by clients; Ensure sufficient quantities, quality, and timeliness are maintained. Conduct technical investigations and risk assessments related with processes.
  • Support generation of SOPs, raw material specifications, master batch records and reports for tech transfer and development processes.
  • Provide process expertise in the resolution of complex, technical or operational problems.
  • Perform independent data recording, analysis and troubleshooting, document development work in concise reports and provide project updates in written and oral presentations.
  • Support internal and external audits.
  • Perform occasional extended hours and weekends to support ongoing lab activities as needed.

Basic Qualifications
Bachelor’s degree in chemical engineering, molecular biology, biochemistry, or related subject area.
Relevant experiences in a process development or clinical manufacturing laboratory setting in downstream bioprocess development for gene therapy or biologics processes.

Preferred Qualifications:
Experience with downstream purification of biological molecules required, with knowledge of downstream operations desired.
Fundamentals and/or modeling of unit operations is a plus.
Technology Transfer
Ability to work and follow safe lab procedures and maintain good laboratory practice (GLP).
Interpersonal and facilitation skills to collaborate with all levels of the organization.

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