DRUG SUBSTANCE PROCESS ENGINEER, ANTIBODY DRUG SUBSTANCE DEVELOPMENT (CONTRACTOR)

Company: Arcus Biosciences Inc.
Location: Hayward
Posted on: October 27, 2024

Job Description:

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 oversight and support to ensure Arcus' DS process is successfully developed, transferred, and manufactured. This position will report to the Director of Antibody Drug Substance Development and work closely with Drug Product and Analytical Sciences groups.
The following information provides an overview of the skills, qualities, and qualifications needed for this role.
ResponsibilitiesThe DS Process Engineer will apply monoclonal antibody purification process knowledge and experience in providing technical oversight and support to CDMO by:

• 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.
• Reviewing batch records and procedures.
• Reviewing GMP operation and process data.
• Supporting investigations and troubleshooting.
• Communicating any issues potentially impacting process development/execution activities and timelines.Qualifications
• In-depth knowledge and broad experience in antibody purification development and manufacturing operations with the ability to collaborate and influence team members and work in a rapidly changing environment.
• BS, MS, or PhD degree in Chemical Engineering, Biochemical Engineering, Molecular Biology, or Biochemistry - 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.
• Strong analytical thinking, organizational, and problem-solving skills.
• Ability to work collaboratively with internal and external partners in a matrix structure to ensure timelines and deliverables are met.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to work independently with minimal guidance.
• Accuracy and attention to detail.This contract role can be based at our Hayward, CA location or can be remote based.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 identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets.
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Keywords: Arcus Biosciences Inc., Citrus Heights , DRUG SUBSTANCE PROCESS ENGINEER, ANTIBODY DRUG SUBSTANCE DEVELOPMENT (CONTRACTOR), Engineering , Hayward, California