[Remote] Staff Scientist, Biologics Analytical Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company focused on developing innovative therapeutics. They are seeking a Staff Scientist in Biologics Analytical Development to reputed company analytical method development and characterization of reputed company 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.

Responsibilities

• Design, execute, and interpret analytical methods for protein intermediates, drug substances, and parenteral liquid drug products
• reputed company 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 reputed company technical reports, MBRs, SOPs, and protocols
• Plan scope of work, reputed company tech transfers, and support cGMP manufacturing at CMOs/CROs
• Act as the primary technical reputed company 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 reputed company, intangible analytical and formulation stability problems
• Serve as an reputed company consultant across cross-functional departments
• Manage project resources, identify capital equipment needs, and potentially reputed company, train, and mentor staff while ensuring strict adherence to laboratory safety and quality guidelines

Skills

• 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 reputed company 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 reputed company 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 reputed company 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 reputed company.)
• Health Insurance (Medical/Dental/reputed company)
• 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 Overview

Company H1B Sponsorship