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Drug Substance Process Engineer - Contract

Company

Arcus Biosciences

Address , Remote
Employment type CONTRACTOR
Salary
Expires 2023-07-30
Posted at 11 months ago
Job Description
Job Summary:

The DS Process Engineer will be responsible for supporting the commercialization of Arcus’ monoclonal antibody therapeutics which are being manufactured at a third-party CDMO. The Process Engineer will interface with the CDMO Process Development, Manufacturing, and Quality to provide technical oversights and supports to ensure Arcus’ DS process is successfully developed, transferred and manufactured. This position will report to Sr. Director of Antibody Drug Substance Development and work closely with Drug Product and Analytical Sciences.

Responsibilit
ies:

The DS Process Engineer will apply cell culture and purification process knowledge and experience in providing technical oversights and supports to CDMO by:
  • Reviewing GMP operation and process data
  • Assisting in evaluation of CDMO’s technical capabilities for antibody process development and production of drug substance
  • Tracking and reviewing technical documents such as study protocols and reports, process validation protocols and reports, and other relevant process development documents
  • Communicating any issues potentially impacting process development/execution activities and timelines
  • Reviewing batch records and procedures
  • Supporting investigations and troubleshooting

Qualifications
(including knowledge & skills):

In-depth knowledge and broad experience in antibody cell culture and purification development and manufacturing operations with the ability to collaborate and influence team members as well as work in a rapidly changing environment.
  • Excellent verbal, written, and interpersonal communication skills
  • BS, MS, or PhD degree in Chemical Engineering, Biochemical Engineering, Molecular Biology, or Biochemistry A minimum of 6 years (BS), 4 years (MS), or 2 years (PhD) experience in a process engineering role in support of drug substance process development and process characterization, and GMP antibody production in both upstream and downstream operations on the manufacturing floor
  • Accuracy and attention to detail
  • Ability to work independently with minimal guidance
  • Strong analytical thinking, organizational, and problem-solving skills
  • Ability to work collaboratively with internal and external partners in a matrix structure to ensure that timelines and deliverables are met


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Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets