Nektar Therapeutics · 20 hours ago
Staff Scientist - Downstream
United States
Full-time
Remote
Lead/Staff
$178K/yr - $193K/yr
10+ years expNektar Therapeutics is seeking a Staff Scientist - Downstream to lead the design and optimization of purification processes for biologic drug substances. This role involves overseeing lab-scale experimentation and collaborating with cross-functional teams to ensure processes are scalable and compliant with program strategies.
BiotechnologyChemicalHealth CareTherapeutics
Responsibilities
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
Qualification
Required
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
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
Preferred
Conjugation expertise is a plus
Benefits
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)
Company
Nektar Therapeutics
Nektar Therapeutics develops therapeutics based on its advanced polymer conjugate chemistry technology platform.
51-200 employees
H1B Sponsorship
Nektar Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (3)
2022 (14)
2021 (15)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$1.31BKey Investors
SFJ PharmaceuticalsAstraZenecaDeerfield
2025-07-01Post Ipo Equity· $115M
2024-11-04Acquired
2024-03-04Post Ipo Equity· $30M
Leadership Team
Jillian B. Thomsen
SVP and Chief Financial Officer
Jonathan Zalevsky
Chief Research & Development Officer
Recent News
New Enterprise Associates
2026-01-13
MarketScreener
2026-01-03
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