Staff Scientist, Process Development - Downstream

Staff Scientist - Downstream

Position Overview

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

Process & Method Development

• 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.

Analytical Characterization & Data Integrity

• 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.

Technology Transfer & Scale‑Up

• 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.

Cross‑Functional Collaboration & Program Support

• 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.

Documentation & Regulatory Contributions

• 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.

Continuous Improvement & Innovation

• 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.

Qualifications

Education

• 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.

Experience & Technical Skills

• 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 in a matrixed environment; 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 standards for data integrity and safety.

Additional Information

Nektar currently anticipates the base salary for the Staff Scientist, Downstream to range from $180,000 to $195,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company''s discretion on an individual basis.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical/Dental/Vision)
• Disability Insurance
• Holiday Pay
• Paid Time Off (PTO)
• 401(k) Match
• Employee Stock Purchase Plan
• Wellness Programs
• Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to https://www.nektar.com/careers.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.