Position Summary

This position will serve as the in-house expert and strategic lead for analytical method development and characterization of complex biologics, including monoclonal antibodies and PEGylated/glycosylated proteins. The successful candidate will design robust, stability-indicating methods for pre-clinical through clinical phases, author CMC sections for regulatory filings (IND/BLA), and provide technical oversight internally and at external contract organizations (CMOs/CROs).

Essential Duties and Responsibilities

• Method Development & Characterization: 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).
• Regulatory & CMC: 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.
• Project & CMO Management: 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.
• Experimental Design & Strategy: Apply independent judgment and data evaluation techniques, including Design of Experiments (DoE), to solve highly complex, intangible analytical and formulation stability problems.
• Leadership & Collaboration: 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.

Minimum Qualification Requirements

Education & Experience

• Degree: PhD in a scientific or engineering discipline (Post-doctoral work may count toward experience). Exceptional candidates with equivalent industry experience will be considered.
• Experience: A minimum of 10 years of biotechnology or pharmaceutical industry experience, with a dedicated focus on biologics analytical development.

Technical Core Competencies

• Analytical Expertise: Proven mastery of analytical method development and characterization for complex proteins (PEGylated, glycosylated, mAbs).
• Instrumentation: Advanced, hands-on experience with mass spectrometry and standard biologics analytical equipment.
• Methodology & Regulations: Strong working knowledge of rational formulation design, protein stability, DoE software, and FDA/cGMP/cGLP regulatory requirements.

Soft Skills & Attributes

• Communication: Exceptional written and verbal communication skills; ability to translate complex scientific data into clear business-critical insights for both technical and non-technical audiences.
• Problem Solving: Superior troubleshooting skills with a track record of scientific creativity, independent thought, and sound judgment.
• Project Management: Excellent organizational and time-management skills, with a proven ability to prioritize and execute multiple concurrent programs in a fast-paced team environment.

 

Additional Information

Nektar currently anticipates the base salary for the Scientist, Biologics Analytical Development to range from $178,000 to $193,000 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.