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Staff Scientist, Biologics Analytical Development jobs in United States
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Nektar Therapeutics · 1 month ago

Staff Scientist, Biologics Analytical Development

Nektar Therapeutics is a biotechnology company focused on developing innovative therapeutics. They are seeking a Staff Scientist in Biologics Analytical Development to lead analytical method development and characterization of complex biologics, including monoclonal antibodies. The successful candidate will also be responsible for authoring CMC sections for regulatory filings and managing project timelines with external partners.
BiotechnologyChemical & MaterialsHealthcareChemicalHealth CareTherapeutics
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Design, execute, and interpret analytical methods for protein intermediates, drug substances, and parenteral liquid drug products
Lead characterization studies utilizing advanced mass spectrometry (LC-MS/MS, MALDI-TOF), structural techniques (HDX, covalent labeling), and impurity analysis (HCP, sequence variants, extractables/leachables)
Author and review regulatory CMC sections for IND/BLA submissions, including analytical characterization, impurity profiling, and structural elucidation
Write and approve complex technical reports, MBRs, SOPs, and protocols
Plan scope of work, lead tech transfers, and support cGMP manufacturing at CMOs/CROs
Act as the primary technical point of contact to ensure project timelines and deliverables are met
Apply independent judgment and data evaluation techniques, including Design of Experiments (DoE), to solve highly complex, intangible analytical and formulation stability problems
Serve as an internal and external consultant across cross-functional departments
Manage project resources, identify capital equipment needs, and potentially lead, train, and mentor staff while ensuring strict adherence to laboratory safety and quality guidelines

Qualification

Analytical method developmentBiologics analytical developmentMonoclonal antibodiesPEGylated proteinsGlycosylated proteinsMass spectrometryLC-MS/MSMALDI-TOFHydrogen-deuterium exchange (HDX)Covalent labelingHost cell protein (HCP) analysisSequence variant analysisExtractables and leachables analysisRegulatory CMC documentationIND/BLA submissionsDesign of Experiments (DoE)CGMP manufacturingProtein stabilityRational formulation designFDA regulatory requirementsCGMP regulationsCGLP regulationsProject management

Required

PhD in a scientific or engineering discipline (Post-doctoral work may count toward experience). Exceptional candidates with equivalent industry experience will be considered
A minimum of 10 years of biotechnology or pharmaceutical industry experience, with a dedicated focus on biologics analytical development
Proven mastery of analytical method development and characterization for complex proteins (PEGylated, glycosylated, mAbs)
Advanced, hands-on experience with mass spectrometry and standard biologics analytical equipment
Strong working knowledge of rational formulation design, protein stability, DoE software, and FDA/cGMP/cGLP regulatory requirements
Exceptional written and verbal communication skills; ability to translate complex scientific data into clear business-critical insights for both technical and non-technical audiences
Superior troubleshooting skills with a track record of scientific creativity, independent thought, and sound judgment
Excellent organizational and time-management skills, with a proven ability to prioritize and execute multiple concurrent programs in a fast-paced team environment

Benefits

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.)
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

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Nektar Therapeutics develops therapeutics based on its advanced polymer conjugate chemistry technology platform.

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
80%
Represents job field similar to this job
Engineering and Development
Accounting and Finance
Management and Executive
Legal and Compliance
Arts and Entertainment
Customer Service and Support
Trends of Total Sponsorships
*2026 (1)
2025 (2)
2024 (1)
2023 (3)
2022 (14)
2021 (15)
2020 (13)

Funding

Current Stage
Public Company
Total Funding
$2.1B
Key Investors
SFJ PharmaceuticalsAstraZenecaDeerfield
2026-04-21Post Ipo Equity· $325M
2026-02-11Post Ipo Equity· $460M
2025-07-01Post Ipo Equity· $115M

Leadership Team

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Jillian B. Thomsen
SVP and Chief Financial Officer
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Company data provided by crunchbase