Lead Biologics Analytical Scientist

Neurocrine Biosciences; San Diego (CA); On-site; USD 157,000 - 214,000; Full time

Job summary

Neurocrine Biosciences in San Diego seeks an Analytical Development Lead for Biologics to guide drug substance and drug product development from preclinical through commercial, lead method development and validation, and contribute to control strategies under cGMP.

You will coordinate cross‑functional teams, transfer methods to manufacturing, and support regulatory filings with deep Biologics analytics expertise including multiple UPLC methods, ELISA, and MS-based analyses.

Qualifications

• BS/BA in Analytical Chemistry or related discipline and 8+ years of experience in the analytical/pharmaceutical development field
• Experience in method transfer in Analytical Chemistry OR MS/MA in Analytical Chemistry or related discipline and 6+ years of experience OR PhD in Analytical Chemistry or related discipline and 4+ years of relevant experience; may include postdoc experience
• Expert knowledge and understanding of Biologics analytical development and a thorough understanding of bioprocess as well as formulation development
• Expert knowledge of Biologics extended characterization, critical quality attribute (CQA) assessment, and structure functional relationship
• Expert knowledge of Biologics stability study
• Extensive experience and expertise with Biologics focusing on analytical method development including but not limited to release/stability method development
• Proficient in characterization of Biologics (e.g. monoclonal antibodies, antibody conjugates) using various modern technologies. They may include but not limited to size exclusion liquid chromatography, reverse phase liquid chromatography, hydrophilic interaction liquid chromatography, ion exchange liquid chromatography, hydrophobic interaction liquid chromatography, mixed mode liquid chromatography, UPLC/HPLC, capillary electrophoresis (Maurice/PA800+), imaged capillary isoelectric focusing (Maurice), gel electrophoresis, mass spectrometry, ELISA, bioassays, and molecular analysis
• Method development, validation, qualification, and transfer experience in Analytical Development
• Comprehensive understanding of cGMP requirements in drug substance and drug product
• Expert knowledge of cross‑functional understanding related to drug development
• Extensive knowledge of FDA, EMA, WHO, and ICH regulatory requirements and experience in IND/IMPD regulatory filing
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent project management skills

Responsibilities

• Lead analytical method development and validation/qualification activities for Biologics within cGMP compliance in support of preclinical through commercialization
• Represent Analytical development on cross‑functional teams
• Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
• Direct laboratory work and/or lab personnel within the company and at external vendors
• Deep technical expertise in separation method development (e.g. SEC‑UPLC, RP‑UPLC, HILIC‑UPLC, IEX‑UPLC, HIC‑UPLC, Mixed Mode‑UPLC, 2D‑LC, CE‑SDS, iCIEF etc.), potency method development (e.g. ELISA, cell‑based bioassay etc.), process related impurities method development (e.g. ELISA, qPCR, LC) for Biologics and extensive knowledge of CQA assessment, analytical comparability, and stability
• Support off‑site analytical method transfers, manufacturing support, and interaction with external vendors
• Provide input into CMC regulatory documentation and supporting work
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC strategies
• Contribute to development of policies and department strategies
• Build and enhance internal and external professional relationships
• Support career development and technical growth of team members
• Present finding at varying levels across the company
• Other duties as assigned

Skills

Biologics analytics knowledge

Cross-functional collaboration

Project management

Communication skills

Problem solving

Education

BS/BA in Analytical Chemistry or related discipline

MS/MA in Analytical Chemistry or related discipline

PhD in Analytical Chemistry or related discipline

Tools

SEC-UPLC

RP-UPLC

HILIC-UPLC

IEX-UPLC

HIC-UPLC

Mixed Mode-UPLC

UPLC/HPLC

CE-SDS

iCIEF

ELISA

Mass spectrometry

qPCR

Job description

Neurocrine Biosciences in San Diego seeks an Analytical Development Lead for Biologics to guide drug substance and drug product development from preclinical through commercial, lead method development and validation, and contribute to control strategies under cGMP.

You will coordinate cross‑functional teams, transfer methods to manufacturing, and support regulatory filings with deep Biologics analytics expertise including multiple UPLC methods, ELISA, and MS-based analyses.