Scientist II, Pharmaceutical Development

neurocrine; San Diego (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Neurocrine Biosciences in San Diego seeks a qualified scientist to Represent Preformulation and Pharmaceutical Development within Technical Operations, focusing on pre-FIH molecules. You will develop phase-appropriate analytical methods and execute preformulation studies across multiple programs.

You will author regulatory submissions and technical reports, identify development risks, implement innovative analytical technologies, and communicate findings to multidisciplinary teams to support R&D

Qualifications

• BS/BA in Chemistry, Biochemistry, Chemical Engineering or related field with 4+ years pharma experience.
• MS/MA in Chemistry, Biochemistry, Chemical Engineering or related field with 2+ years relevant experience or PhD with some experience.
• Cross-functional understanding of molecule selection and drug development is preferred.
• Technical expertise in analytical method development and preformulation sciences.
• Technical expertise in LC-MS is strongly preferred.
• Familiarity with various pharmaceutical dosage forms to design developability studies.
• Strong knowledge of regulatory guidelines for preparing and authoring submissions.

Responsibilities

• Collaborate with R&D teams to share developability data broadly.
• Design and develop phase-appropriate analytical methods (HPLC-UV, LC-MS, MS-MS, SEC-HPLC).
• Design and execute developability studies (solubility, stability, excipient compatibility).
• Research new instrumentation and analytical technologies for development support.
• Review electronic lab notebooks, technical reports, stability summaries, and regulatory submissions.
• Maintain information repository for early development data and properties.
• Present updates at department meetings and deliver talks on new techniques.
• Lead or participate in project team meetings and report progress/gaps.
• Other duties as assigned.

Skills

Analytical method development

LC-MS expertise

Developability assessments

Regulatory documentation

Cross-functional collaboration

Education

BS/BA in Chemistry or related

MS/MA in Chemistry or related

PhD in Chemistry or related

Tools

Agilent OpenLab

HPLC-UV

SEC-HPLC

MS/MS instrumentation

Job description

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are 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 for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie )

About the Role

Represent Preformulation and Pharmaceutical Development within Technical Operations by collaborating on project teams from early discovery through development, predominately focusing on pre-FIH molecules in a fast-paced non-GMP environment. The candidate will develop phase appropriate fit-for-purpose analytical methods, design and execute preformulation studies for multiple preclinical/clinical programs, identify developability risks for potential development candidates. Additionally, this role is responsible for authoring and reviewing technical documentation including regulatory submissions and scientific reports. Success in this role will require sound technical judgment, the ability to identify development risks, implementation of innovative analytical technologies, and effectively communicate complex scientific findings to multidisciplinary teams to support R&D decision-making.

Your Contributions

• Collaborate with Research/Discovery, Preclinical & Clinical Pharmacology, and Technical Operations to facilitate communication, ensuring emerging and updated pharmaceutical development data is shared widely and used effectively by the broader R&D Team
• Design and develop phase appropriate analytical methods (HPLC-UV, LC-MS, MS-MS, SEC-HPLC, etc.) studies in support of early pharmaceutical development activities
• Design and execute studies in support of developability assessments (i.e. thermodynamic & kinetic solubility, chemical & physical stability, excipient compatibility, etc.), preclinical formulation development, and support molecule/form selection
• Research new instrumentation and analytical technologies to be implemented when needed for development support
• Scientific review of electronic lab notebooks, technical development reports, stability summaries, DFA memos, regulatory submissions, and other relevant documentation
• Assemble and/or maintain information repository to allow efficient retrieval of early pharmaceutical development data, physiochemical properties, and scientific knowledge regarding molecules in the R&D pipeline
• Present updates at department meetings and deliver scientific talks on current and new techniques/technology in support of early pharmaceutical development
• Lead or participate in weekly or bi-weekly project team meetings and inform both up and down the chain of command as to progress, resource gaps, and timelines
• Other duties as assigned

Requirements

• BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field AND 4+ years of pharmaceutical industry experience, including experience in a chemistry, analytical, or characterization laboratory setting OR
• MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field AND 2+ years of similar experience noted above OR
• PhD in Chemistry, Biochemistry, Chemical Engineering, or related field AND some relevant experience; may include postdoc experience
• Demonstration of cross-functional understanding related to molecule selection and drug development is strongly preferred
• Must have technical expertise in analytical method development and preformulation sciences
• Technical expertise in LC-MS is strongly preferred
• Working knowledge of Agilent OpenLab software is a plus
• Expertise with fit-for-purpose method development and phase appropriate method qualification/ validation to determine solubility, stability, and other pharmaceutically relevant properties of novel therapeutics (including small molecules, peptides, and other biologic modalities)
• Familiarity with a variety of pharmaceutical dosage forms (parenteral, oral solutions/suspensions, SDD, HME, SEDDS, etc.) to design appropriate developability studies and identify potential development risks
• Strong knowledge of regulatory guidelines in preparing and authoring