Director, Downstream Process Development (Biotech)

Location: South San Francisco, United States; in-person or virtual work at Marea or CDMO sites, with travel to CDMO sites averaging up to 20%.

Company

Clinical-stage biotechnology company developing genetically validated therapies for cardioendocrine diseases, including monoclonal antibody and metabolic disease programs.

What you will do

• Develop downstream process conditions and control strategies for CHO-derived monoclonal antibodies.
• Identify and qualify unit operations, raw materials, equipment, sampling plans, in-process testing, and process controls.
• Lead process optimization, scale-up, continuous improvement, troubleshooting, deviation investigations, root cause analysis, and CAPAs.
• Provide technical oversight of CDMO development and manufacturing activities and transfer operations between CDMOs.
• Prepare technical data packages and contribute to FDA and other regulatory submissions, including comparability assessments.
• Develop and maintain cost models for the downstream processes and collaborate with Drug Product, Analytical, Quality, Regulatory, Clinical Development, Project Management, and Legal teams.

Requirements

• PhD in Chemical Engineering, Microbiology, Biology, or a related discipline with more than 8 years of relevant experience, or BS/MS with more than 10 years of relevant biotech or pharmaceutical experience.
• Hands-on experience developing, scaling up, and tech transferring downstream processes for CHO-derived monoclonal antibodies.
• Experience working with CDMOs on process development, tech transfer, scale-up, and at-scale manufacturing operations.
• Knowledge of cGMPs, drug development workflows, CMC, product attributes, analytical methods, and process risk mitigation.
• Ability to independently write technical reports based on data analysis and experimental design, communicate effectively, and deliver against timelines.
• Ability to work cooperatively in person or virtually and travel to CDMO sites as required.

Nice to have

• Experience or familiarity with cell banking, cell culture, formulation, or analytical development.
• Experience working in a lean start-up environment with external consultants and outsourced technical resources.

Culture & Benefits

• Hands-on role in a lean, dynamic clinical-stage biotechnology environment.
• Collaborative working style with colleagues and external CDMO, consulting, and advisory resources.
• Opportunity to support programs advancing toward late-stage and early-stage clinical development.