Senior Scientist, Analytical Development (Small Molecule)

Neurocrine Biosciences; San Diego (CA); On-site; USD 110,800 - 151,000; Full time

Benefits offered by this job

Annual bonus target of 20%

Retirement savings plan with company match

Paid vacation and medical leave

Job summary

Neurocrine Biosciences is seeking a Senior Scientist for Analytical Development to manage analytical activities for drug substances from preclinical to commercial phase. The role involves developing methods, validating procedures, and ensuring compliance with regulatory standards.

Ideal candidates will possess a relevant degree, significant experience in analytical chemistry, and strong problem-solving abilities. This position offers a salary between $110,800 and $151,000 along with benefits including health coverage and an annual bonus.

Qualifications

• 5+ years of experience in the analytical/pharmaceutical development field or equivalent.
• Hands-on experience in method development and validation in analytical chemistry.
• Strong technical expertise in testing, verification, validation, and characterization.

Responsibilities

• Perform development and optimization of phase‑appropriate analytical methods.
• Lead and execute analytical development activities for assigned projects.
• Ensure compliance with cGMP and communicate results through technical reports.

Skills

Analytical method development

Analytical chemistry

Communication skills

HPLC

cGMP compliance

Problem-solving skills

Education

BS/BA in Chemistry, Biochemistry, or related discipline

MS/MA in Chemistry or related discipline

PhD in Analytical Chemistry or related discipline

Tools

HPLC

GC

MS

IR

UV

Job description

Senior Scientist, Analytical Development

The Senior Scientist, Analytical Development, is responsible for analytical development activities for small molecule drug substances from preclinical through commercial phase. This laboratory-focused role requires deep expertise in analytical chemistry and strong problem‑solving skills. The Senior Scientist independently manages analytical activities for assigned programs, including development, execution, validation, transfer, and troubleshooting of methods used to control raw materials, in‑process, intermediates, and final products. The role also oversees analytical work performed at external CROs and CDMOs, conducts work in compliance with cGMP, safety, and regulatory requirements, and collaborates cross‑functionally with teams across CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development, manufacturing readiness, and regulatory submissions.

Your Contributions

• Perform development and optimization of phase‑appropriate analytical methods for starting materials, intermediates, and drug substances to support programs from early development through commercialization using techniques such as HPLC, GC, MS, IC, FTIR, UV, NMR, KF, and other relevant techniques.
• Perform analytical method verification and validation within cGMP compliance and in accordance with regulatory guidelines.
• Perform analytical development activities for the characterization of small molecules utilizing various chemical‑physical characterization techniques.
• Develop stability studies, forced degradation studies, and support impurity identification.
• Independently lead and execute analytical development activities and contribute to overall control strategy for assigned projects.
• Provide scientific leadership and technical support for quality investigations, including OOS/OOT events, deviations, root cause analyses, and CAPAs.
• Maintain accurate and comprehensive laboratory documentation in compliance with company procedure.
• Represent analytical development on cross‑functional teams and maintain accountability for analytical deliverables and progress on CMC and manufacturing plans.
• Conduct laboratory work independently and/or train lab personnel within the company and at external vendors.
• Support CMC regulatory documentation and filings as needed, and off‑site analytical transfers, manufacturing support, and interaction with contractors.
• Clearly communicate analytical results, risks, and recommendations through high‑quality technical reports, presentations, and cross‑functional discussions.
• Ensure safe laboratory practices and develop novel concepts and techniques to support analytical activities with chemical and product development.
• Contribute to development of policies and department strategies, build and enhance internal and external professional relationships, and support career development and technical growth of team members.

Requirements

• BS/BA in Chemistry, Biochemistry, or related discipline with 5+ years of experience in the analytical/pharmaceutical development field; OR MS/MA in Chemistry or related discipline with 3+ years of experience; OR PhD in Analytical Chemistry or related discipline with relevant experience (postdoc experience acceptable).
• Hands‑on experience in method development, validation, transfer, and execution in analytical chemistry.
• Strong technical expertise in testing, method development, verification, validation, characterization, and support of stability studies for small molecule programs.
• Technical proficiency with techniques that include, but are not limited to, HPLC, UPLC, GC, KF, IC, IR, MS, spectroscopy, UV, and XRPD.
• Experience and understanding of analytical chemistry, pharmaceutical development, and phase‑appropriate control strategies.
• Excellent interpersonal skills with strong oral and written communication abilities, including drafting and reviewing technical documents.
• Excellent laboratory and productivity skills.
• 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.

Compensation & Benefits

The annual base salary for this position is estimated to be between $110,800.00 and $151,000.00. Individual pay decisions depend on various factors such as primary work location, complexity and responsibility of role, and relevant experience and skills. This position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in the company’s equity‑based long‑term incentive program. Benefits include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental, and vision coverage in accordance with the applicable plans.

EEO Statement

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment.