Principal Scientist, Analytical Development

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Responsible for analytical development to support research and development, tech transfer and characterization of biologics drug substance and drug product processes including cell-line development, as well as of batch or sample testing/release/stability and regulatory document contribution. Provides project management and coordination for analytical in support of projects at various stages of development. Provides analysis and evaluation of biologics material and products at all stages of the development process. Monitors and evaluates completion of tasks and projects.

Requirements

• BS/BA in Chemistry/ Biochemistry or related discipline and 12+ years of experience in the analytical/pharmaceutical development field. Experience in method transfer in Analytical Development OR MS/MA in Chemistry or related discipline and 10+ years of experience OR PhD in Chemistry/ Biochemistry or related discipline and 4+ years of relevant experience; may include postdoc experience
• Thorough understanding of analytical chemistry & method development for biologics and a well-developed understanding of biologics process development (cell-line, upstream and downstream), and drug product development
• Hands on experience and strong expertise with biologics impurities method development. Required skills include but are not limited to qPCR, ddPCR, ELISA, and western blot
• Proficiency to advance program as analytical development lead
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity skills
• Method transfer experience in Analytical Development
• Good understanding of cGMP requirements in drug substance and drug product
• Demonstration of cross-functional understanding related to biologics drug development
• Assimilates data and research findings outside of Neurocrine for application to new scientific projects
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
• May develop an understanding of other areas and related dependencies
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple programs, teams and/or departments
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills

Responsibilities

• Lead analytical method development and qualification/validation activities for the characterization of antibody and antibody conjugate utilizing various analytical techniques including but not limited to SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, HIC-UPLC, Mixed Mode-UPLC, 2D-LC, CE-SDS, iCIEF, Bioassays (ELISA, cell-based assays), qPCR, LC-MS, NGS
• Support cell line development to enable faster and informed decision making when needed. Key analytical areas for cell line development include but are not limited to high throughput titer analysis, purity analysis, N-glycan analysis, charge variant analysis, sequence variant analysis, genomic integrity analysis
• Represent analytical development on CMC cross-functional teams and maintain accountability for analytical deliverables
• Lab Personnel and ensure laboratory safety practices
• Support off-site analytical method transfers, manufacturing support, and interaction with external vendors when needed
• Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC development strategies
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees