Director, Downstream Bioprocess Development - Hybrid

BioSpace; South San Francisco (CA); On-site; USD 190,000 - 270,000; Full time

Job summary

Marea Therapeutics, based in South San Francisco, seeks a Director of Downstream Development to lead end-to-end CHO‑derived monoclonal antibody downstream processing, scale-up, and tech transfer. You will work closely with CDMOs and internal teams to enable late-stage development and regulatory submissions.

The role requires hands-on leadership in a lean startup environment, on-site presence at least three days per week, and collaboration across Regulatory, Quality, and Analytical groups to

Qualifications

• Minimum 8+ years with PhD or 10+ years with BS/MS in Biotech/Pharma, downstream bioprocess development.
• Experience scaling, tech transfer, and CDMO collaboration for CHO-derived mAbs.
• cGMP knowledge in a virtual manufacturing setting with outsourced production.
• Strong technical writing and data analysis for regulatory support.
• Excellent communication and stakeholder management with CDMOs.
• Ability to work on-site with flexibility and timelines.

Responsibilities

• Develop downstream process conditions and unit operations for CHO-derived monoclonal antibodies.
• Oversee tech transfer and scale-up from clinical to commercial manufacturing.
• Provide technical oversight of CDMO activities and troubleshoot deviations and CAPAs.
• Develop control strategies and data packages for comparability and regulatory submissions.
• Collaborate with Drug Product, Analytical, Quality, Regulatory, Clinical Development and Project Management teams.

Education

PhD or BS/MS in Biotech/Pharma with relevant downstream experience

Job description

Marea Therapeutics, based in South San Francisco, seeks a Director of Downstream Development to lead end-to-end CHO‑derived monoclonal antibody downstream processing, scale-up, and tech transfer. You will work closely with CDMOs and internal teams to enable late-stage development and regulatory submissions.

The role requires hands-on leadership in a lean startup environment, on-site presence at least three days per week, and collaboration across Regulatory, Quality, and Analytical groups to