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About the Role

Lead protein sciences and external manufacturing for programs advancing toward the clinic. Serve as the technical lead for CDMOs across process development, analytical development, and drug substance/product. Build and manage research-stage expression, purification, and analytical capabilities in-house and through external CROs.

Responsibilities

• Serve as the technical lead to external manufacturing partners across cell line development, upstream and downstream process development, analytical method development, and GMP drug substance and drug product for gene to IND CMC programs.
• Ensure external programs deliver drug product to specification, on time, and on budget.
• Communicate program progress, risks, and key decisions to the internal leadership team.
• Support ongoing process development for clinical stage programs, including early high-concentration formulation development to enable subcutaneous dosing.
• Build recombinant antibody expression, in house and through external CROs, spanning 96-well / deep-well high-throughput transient screening and mL-to-L bench-scale transient mammalian production to support research and in vivo studies.
• Run the expression pipeline as an internal service with clear intake, prioritization, and turnaround, tracking titer, yield, and quality.
• Optimize transient production of multi-chain bispecific and multispecific assemblies, including plasmid chain-ratio tuning to maximize correctly assembled product.
• Increase expression and screening throughput to support AI/ML-driven design, build, and test cycles.
• Build antibody and bispecific purification trains: Protein A capture with orthogonal polishing by ion exchange, hydrophobic interaction, and mixed-mode chromatography, plus analytical and preparative size-exclusion.
• Develop format-specific strategies that resolve bispecific product-related species from the correctly paired heterodimer.
• Operate AKTA-scale chromatography and high-throughput magnetic-bead purification to support candidate triage and research supply.
• Deliver low-endotoxin, high-monomer, clinically representative material meeting in vivo dosing specifications for pharmacology and toxicology studies.
• Manage and improve internal developability and characterization capabilities (e.g., analytical SEC, HIC, DSF, CE-SDS (reduced and non-reduced), and DLS).
• Confirm correct chain pairing and quantify product-related species for bispecific and multispecific molecules.
• Own developability triage and candidate ranking, and feed results into lead selection with Antibody Engineering colleagues.
• Mentor and grow a small internal protein sciences team and set the day-to-day practices and priorities for the function.
• Partner across Antibody Engineering, Computational Biology, Pharmacology, and program teams, and represent Protein Sciences in program reviews.

Requirements

• PhD in protein science, biochemistry, biophysics, chemical or biological engineering, or a related discipline with 6+ years (Associate Director) or 9+ years (Director) of biopharmaceutical industry experience; or an MS with commensurate additional directly relevant experience.
• Demonstrated experience managing external CDMOs to deliver large-molecule drug substance and drug product on time and on budget.
• Familiarity supporting Module 3 (CMC) of IND filings.
• Experience with bispecific antibodies or other complex antibody formats (e.g. knob-into-hole, multispecific, VHH / single-domain fusions).
• Experience with mammalian expression and cell line development, including transient systems (Expi293, ExpiCHO) and stable cell line development.
• Experience building and optimizing multi-step antibody purification trains on FPLC systems (AKTA or equivalent), including Protein A capture and common polishing modalities (IEX, HIC).
• Working knowledge of core biophysical and analytical methods (analytical SEC, HIC, DSF, CE-SDS, DLS).
• Developability triage experience translating biophysical data into candidate selection decisions.
• Experience with liquid-handling automation and high-throughput antibody purification and characterization.
• High-concentration (greater than 100 mg/mL) subcutaneous formulation development and management of outsourced formulation programs.
• Track record advancing a biologic through IND-enabling CMC.
• Knowledge of T-cell engaging antibody platforms (TCEs, bispecifics, multispecifics) and a background in oncology or immuno-oncology.
• Proficiency in a programming language (e.g. Python) and experience with AI-assisted or agentic coding tools.

Skills

• Protein expression
• Protein purification
• Analytical development
• Process development
• External manufacturing
• CDMO management
• Cell line development
• Mammalian expression
• Transient expression systems (Expi293, ExpiCHO)
• Stable cell line development
• FPLC systems (AKTA)
• Protein A capture
• Ion exchange chromatography (IEX)
• Hydrophobic interaction chromatography (HIC)
• Mixed-mode chromatography
• Size-exclusion chromatography (SEC)
• Biophysical characterization
• Developability triage
• Liquid-handling automation
• High-throughput purification
• High-throughput characterization
• Formulation development
• IND filings (Module 3 CMC)
• Bispecific antibodies
• Multispecific antibodies
• Knob-into-hole technology
• VHH / single-domain fusions
• Oncology
• Immuno-oncology
• Python programming
• AI-assisted coding tools

Location

• South San Francisco

Work Type

• Hybrid
• Onsite

Experience Level

• Associate Director
• Director

Education Level

• PhD
• MS