Scientist II, Analytical Development
About The Position
Neurocrine Biosciences is a biopharmaceutical company focused on discovering, developing, and commercializing treatments for neurological, psychiatric, endocrine, and immunological disorders. The Scientist II, Analytical Development supports analytical development activities for small-molecule drug substances from preclinical through commercial phases. This is a laboratory-focused role requiring analytical chemistry expertise and problem-solving skills. With supervision, the scientist independently supports method development, execution, validation, transfer, and troubleshooting for methods used to control raw materials, in-process materials, intermediates, and final products. The role also helps oversee analytical work performed by external CROs and CDMOs. The scientist conducts work in compliance with cGMP, safety, and regulatory requirements and collaborates across CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners. The position supports product development, manufacturing readiness, and regulatory submissions, and contributes to control strategy development and scientific and technical alignment throughout product development. Responsibilities span research and development, technology transfer, commercialization, batch testing and release, regulatory documentation, project management, laboratory oversight, and professional development of laboratory personnel.
Requirements
- A bachelor's degree in chemistry or a closely related field and 4 years of pharmaceutical-industry experience focused on analytical chemistry; alternatively, a master's degree in chemistry or a closely related field and 2 years of similar experience, or a PhD or equivalent in chemistry or a closely related field with relevant experience, which may include postdoctoral experience.
- Extensive hands-on pharmaceutical analysis experience and method development and validation experience for various active ingredients and/or dosage forms.
- Solid understanding of project and group goals and methods, and ability to explain the process behind data and the implications of results.
- Strong knowledge of one or more scientific disciplines and scientific principles, methods, and techniques; developing expertise in one discipline.
- Strong knowledge and demonstrated ability working with a variety of laboratory equipment and tools.
- Ability to work as part of a team and potentially train more junior staff; ability to lead teams.
- Excellent computer skills and strong communication, problem-solving, and analytical-thinking skills.
- Attention to detail while maintaining perspective on broader scientific impact on the team.
- Ability to meet multiple deadlines with a high degree of accuracy and efficiency.
- Strong project-management skills and effective report-writing and oral-presentation skills.
- Excellent written and verbal communication skills.
- Ability to build effective working relationships and maintain confidentiality regarding company intellectual property and proprietary work.
- Ability to creatively solve complex problems in a team environment and demonstrate cross-functional understanding of drug development.
- Working knowledge of regulatory requirements for drug product commercialization, NDA preparation, and cGMP, including quality assurance and quality control practices and issues.
- Working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD.
Responsibilities
- Support analytical development for research and development, technology transfer, and commercialization of drug substance and drug product processes.
- Oversee batch testing and release and contribute to regulatory documents through managerial and individual input.
- Provide analytical project management for Chemical and Product Development projects.
- Analyze and evaluate materials and products at all stages of development.
- Monitor and evaluate completion of tasks and projects; plan and manage projects.
- Represent Analytical Chemistry on cross-functional teams and maintain accountability for analytical deliverables and progress on R&D and manufacturing plans.
- Independently design, plan, and execute analytical chemistry project activities supporting preclinical through commercial work.
- Supervise laboratory work and/or laboratory personnel and ensure safe laboratory practices.
- Develop and optimize analytical methods from preclinical development through commercialization.
- Create and implement novel ideas and techniques to support analytical activities with Chemical and Product Development.
- Support off-site analytical transfers, manufacturing, and interactions with contractors.
- Provide input to CMC regulatory documentation and supporting work.
- Guide laboratory personnel and contribute to their professional development.
- Contribute to policies and department strategies; build and enhance internal and external professional relationships.
- See projects through to completion and effectively negotiate, persuade, and influence.
- Perform other duties as assigned.
Benefits
- Annual bonus with a target of 20% of earned base salary
- Eligibility to participate in an equity-based long-term incentive program
- Retirement savings plan with company match
- Paid vacation, holidays, and personal days
- Paid caregiver, parental, and medical leave
- Medical, prescription drug, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
