Senior Scientist, Analytical Development & Drug Substance

Cytokinetics; San Francisco (CA); Presencial; USD 162 000 - 189 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Stock options

Health insurance

Dental, vision, life and disability"保险

401k with employer match

Learning & wellness stipends

Paid time off

Resumo da oferta

Cytokinetics is seeking a hands-on Senior Scientist, Analytical Development, to support in-house analytical development across our small molecule pipeline. You will design and execute analytical studies to support drug substance and drug product development from early research through clinical development.

The role requires expertise in chromatographic, spectroscopic, and physicochemical characterization techniques, and collaboration with Process Chemistry, Formulation Development, DMPK, and

Qualificações

• BS/MS in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field; PhD preferred but not required.
• 5+ years of pharmaceutical industry experience in analytical development, quality control, or related analytical laboratory environments.
• Strong hands-on experience with analytical characterization of small molecule drug substances and drug products.
• Demonstrated expertise with HPLC/UHPLC and other analytical techniques such as LC-MS, GC, dissolution, Karl Fischer titration, XRPD, DSC/TGA, particle size analysis, and related instrumentation.
• Experience developing, optimizing, qualifying, and troubleshooting analytical methods.
• Strong laboratory skills with the ability to independently design experiments, interpret results, and solve technical problems.
• Familiarity with cGMP requirements and pharmaceutical development practices.
• Excellent technical writing and documentation skills.
• Strong communication and collaboration skills with the ability to work effectively in cross-functional teams.
• Ability to manage multiple priorities in a dynamic and fast-paced development environment.

Responsabilidades

• Design, execute, and document analytical studies supporting drug substance and drug product development.
• Develop, optimize, qualify, and troubleshoot analytical methods used for release, stability, characterization, and process support testing.
• Perform hands-on laboratory testing using chromatographic, spectroscopic, and physicochemical analytical techniques.
• Characterize drug substances, intermediates, degradation products, excipients, and drug products to support development programs.
• Generate, analyze, interpret, and present scientific data to support development decisions and project milestones.
• Collaborate with Process Chemistry, Formulation Development, DMPK, Pharmacology, and Manufacturing teams to address analytical and technical challenges.
• Support analytical investigations associated with atypical results, laboratory events, and method performance issues.
• Maintain laboratory instruments and equipment, including calibration, qualification, troubleshooting, and routine maintenance activities.
• Prepare and review analytical protocols, study reports, technical summaries, and laboratory documentation.
• Support analytical method transfers, validation activities, specification development, and stability studies as needed.
• Contribute to laboratory operational excellence through process improvements, scientific innovation, and knowledge sharing.

Conhecimentos

Analytical chemistry

HPLC/UHPLC

LC-MS

GC

Dissolution testing

Karl Fischer titration

XRPD

DSC/TGA

Particle size analysis

Data interpretation

Cross-functional collaboration

Technical writing

Formação académica

BS/MS in Analytical Chemistry or related

PhD preferred

Ferramentas

HPLC/UHPLC

LC-MS

GC

Dissolution

Karl Fischer titration

XRPD

DSC/TGA

Particle size analysis

Descrição da oferta de emprego

Cytokinetics is seeking a hands-on Senior Scientist, Analytical Development, to support in-house analytical development across our small molecule pipeline. You will design and execute analytical studies to support drug substance and drug product development from early research through clinical development.

The role requires expertise in chromatographic, spectroscopic, and physicochemical characterization techniques, and collaboration with Process Chemistry, Formulation Development, DMPK, and