Principal Scientist, Analytical Development

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline of compounds in mid- to late-phase clinical development.

About The Role

This position will serve as the analytical lead for multiple projects, with a focus on oligonucleotides and/or bioconjugates. Guide analytical activities related to drug substance and drug product development from preclinical through commercial phase. Develop, establish, and validate/qualify testing methods used to control raw materials, in-process materials, intermediates, drug substance, and drug products. Contribute to the development and implementation of control strategies, with an emphasis on advancing innovation in analytical techniques and platforms. Ensure work complies with cGMP, safety, and regulatory requirements.

Responsibilities

• Lead analytical development activities for analysis and characterization of oligos and/or antibody oligo conjugate (AOC) utilizing IP-RP, AEX, LC-MS, MS/MS, SEC techniques
• Lead analytical methods development and qualification involving process validation and validation of analytical methods within cGMP compliance in support of preclinical through commercialization
• Represent Analytical Development on cross-functional teams and maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
• Conduct laboratory work independently and/or train lab personnel within the company and at external vendors
• Ensure safe laboratory practices
• Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development
• Support off-site analytical transfers, manufacturing support, and interaction with contractors
• Author analytical-related CMC regulatory documents and lead the 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 findings at varying levels across the company
• Other duties as assigned

Requirements

• BS/BA in Analytical Chemistry/Biochemistry or related discipline and 15+ years of experience in the analytical/pharmaceutical development field
• OR MS/MA in Analytical Chemistry or related discipline and 13+ years of experience
• OR PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience
• Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development
• Experience and expertise with oligos and/or bioconjugate 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
• Proficient in characterization of oligos and/or antibody oligo conjugate (AOC) using various modern technologies, such as LC (RP, SEC, IE), LC-MS, Capillary Electrophoresis, MS/MS
• 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
• Knowledge of FDA, EMA, WHO, and ICH regulatory requirements

Pay

The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity-based long-term incentive program.

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