Staff Scientist - Downstream

Nektar has an exciting opportunity for a Staff Scientist - Downstream on the Process Engineering & Scale Up Biologics team.

The Staff Scientist – Downstream leads the design, development, and optimization of purification processes for biologic drug substances (e.g., monoclonal antibodies, recombinant proteins, vaccines). The role spans overseeing lab‑scale experimentation through tech transfer to pilot plant/GMP manufacturing, ensuring processes are scalable, robust, compliant, and aligned with program CMC strategies. It is highly cross‑functional, partnering with Upstream, Analytical, Formulation, Quality, Regulatory, and Manufacturing teams to advance candidates from preclinical through clinical phases.

• Design, execute, and optimize downstream purification unit operations (e.g., affinity, IEX, HIC chromatography; viral inactivation/removal; TFF/crossflow) to deliver scalable, high‑yield, high‑purity processes that meet target CQAs.
• Build and refine scale‑down models, define CPPs/KPP ranges, and assess process robustness to support clinical manufacturing readiness.

• Review and interpret protein analytics (e.g., HPLC/UPLC, CE, biophysical methods) to guide purification strategy, establish in‑process controls, and troubleshoot product quality attributes.
• Document experimental plans, results, and conclusions with high scientific rigor, ensuring traceability and compliance with internal quality systems.
• Lead tech transfer of downstream processes from development to pilot/GMP sites: author/own process descriptions, POEs, batch records, and transfer reports; provide on‑floor support during engineering and clinical campaigns.
• Collaborate with internal/external manufacturing teams to resolve technical gaps, adapt processes to facility constraints, and ensure safe, compliant operations.

• Serve as the DSP representative on CMC teams; integrate with Upstream, Analytical Development, Formulation, Quality, and Regulatory to align development plans, timelines, and deliverables.
• Prepare and deliver technical presentations and updates to project leadership, governance, and external partners/CMOs.

• Draft and review SOPs, batch records, study protocols/reports, and sections for regulatory submissions (e.g., IND/IMPD/CMC), ensuring clarity and completeness for health authority review.
• Evaluate novel resins, membranes, automation, and PAT approaches; pilot innovations to enhance yield, throughput, and cost‑effectiveness.
• Mentor junior scientists/associates in experimental design, good documentation practices, and safe laboratory operations.

• Ph.D. in Biochemistry, Chemical/Biochemical Engineering, Protein Science or related discipline; or M.S. with 10+ years or B.S. with 12+ years relevant industry experience in downstream process development.

A minimum of 10 years work experience in a research and/or development environment is required. Post-doctoral work may serve as experience.

• Demonstrated expertise in protein chromatography (affinity, IEX, HIC), viral clearance (inactivation/filtration), and filtration (TFF/crossflow) from lab to pilot scale. Conjugation expertise is a plus.
• Hands‑on with ÄKTA systems and control software (e.g., UNICORN); proficiency in column packing/unpacking and membrane operations.
• Familiarity with cGMP expectations for clinical manufacturing and authoring of cGMP‑aligned documentation.
• Proven ability to independently design experiments, interpret complex datasets, and troubleshoot purification and product‑quality issues.
• Experience collaborating with Manufacturing, supporting engineering/clinical runs, and executing process transfers.
• Strong cross‑functional communication and stakeholder management; ability to present complex data clearly to technical and non‑technical audiences.
• Must possess excellent oral and written communication skills.
• Results oriented, organized, and thorough, with high safety.

Nektar currently anticipates the base salary for the Staff Scientist,…