Associate Scientific Director, Analytical Development

Neurocrine Biosciences • San Diego, CA

2d • $173,600 - $237,000 • Onsite

About The Position

This position will serve as a subject matter expert and analytical liaison for research and early-stage development projects, with a focus on mass spectrometry characterization of antibodies, conjugates, and other large molecules. Evaluate the developability of development candidates by performing structure elucidation, chemical stability assessments, and forced degradation studies. Accumulate product and process understanding to guide lead-optimization, process development, and formulation development. Serve as Analytical Development Lead and support and oversee all the analytical activities related to drug substance and drug product development from preclinical through commercial phases, including method development, validation/qualification, specification establishment, and control strategy development. Contribute to biomarker discovery via proteomics analysis and targeted quantification across modalities and functional areas. Responsible for keeping work in compliance with GxP, safety, and regulatory requirements. Contribute to analysis and evaluation of material and products at all stages of development process. Supervise junior scientists through coaching and evaluating completion of tasks and projects.

Requirements

• BS/BA and 15+ years of experience, OR MS/MA and 13+ years of experience, OR PhD or equivalent and 10+ years of relevant experience
• Deep expertise in MS-based primary and higher-order structure characterization, physicochemical and biophysical analysis, spectroscopy, and thermodynamic/hydrodynamic characterization, with demonstrated ability to link molecular attributes to stability, efficacy, and biological function
• Experience and expertise with antibody, conjugates, and/or peptides compounds, including biologics upstream and downstream process development, formulation of injectable and intramuscular biologics, process characterization
• Excellent interpersonal skills with strong oral and written communication abilities
• Excellent laboratory and productivity skills
• Proficient in characterization of antibody and/or peptides compounds using various modern technologies. They may include but not limited to various Mass Spectrometry technologies, LC-MS, HPLC, Capillary Electrophoresis, peptide mapping, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization cell-based potency assays
• Method development, validation, and transfer experience in Analytical Development
• Comprehensive understanding of cGMP requirements in API and drug product
• Expert knowledge of cross-functional understanding related to drug development
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
• Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
• Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects
• Leads the development of intellectual property
• May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills

Responsibilities

• Establish collaborative and productive working relationships with key partner organizations to build cross-project analytical alignment and consistent developability criteria through a matrix, cross-functional analytical characterization strategy aligned with broader business objectives
• Define discovery-stage critical quality attributes (CQAs) aligned with target product profiles (TPPs) to guide molecule engineering and optimization, support risk-based developability assessment, and establish early product and process understanding
• Evaluate development candidate developability by performing structure elucidation, chemical stability and forced degradation studies. Collect developability and characterization data to guide lead-optimization within Research, process and formulation development within Technical Operations
• Serve an Analytical Lead in leading analytical development activities for the characterization of antibodies and other large molecules utilizing LC-MS, Capillary Electrophoresis, peptide mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis, HPLC, and modern glycoprotein & carbohydrate characterization techniques
• Lead analytical methods development and qualification involving process validation and the validation of analytical methods 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
• Ensure safe laboratory practices
• 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
• Partner cross-functionally with Biologics Research, Pharmacology, Translational Sciences, DMPK, Toxicology, Clinical Development, Project Leadership, and Business Development to advance programs and inform strategic decision-making
• Support career development and technical growth of team members
• Present finding at varying levels across the company
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree