Senior Process Chemist 2, Drug Substance Development

Role Summary

The Senior Process Chemist 2, Drug Substance Development will be responsible for designing, optimizing, and scaling synthetic chemical processes for active pharmaceutical ingredients (APIs). This role will work closely with cross-functional teams to ensure that new processes are efficient, cost-effective, safe, and compliant with regulatory standards for large-scale manufacturing. This position will report to the Director, Drug Substance Development CMC. The Technical Operations team collaborates with a global network of CROs and CDMOs. This role supports the company’s efforts to discover and develop small molecule therapeutics for rare endocrine disorders and is located in San Diego.

Responsibilities

• Develop and optimize synthetic routes for APIs from lab to pilot-plant scale.
• Collaborate with analytical chemistry and formulation teams to characterize intermediates and final products.
• Conduct risk assessments to ensure safety and environmental compliance.
• Generate process documentation, including batch records, SOPs, and technical reports.
• Explain complex scientific and technical concepts, influencing others to adopt new points of view.
• Manage daily activities of a small functional group, identifying ways to improve efficiencies and best practices within the work unit.
• Contribute to key reviewed scientific/technical documents, expert reports, or patents that enhance the company‚Äôs intellectual capital.
• Evaluate scalability and robustness of chemical processes using Design of Experiments (DoE).
• Lead technology transfer of processes to manufacturing and CDMOs.
• Troubleshoot process issues and implement improvements for cost, yield, and quality.
• Stay up-to-date on regulatory requirements, including cGMP and ICH guidelines.
• Support regulatory filings (INDs, IMPDs, NDAs, briefing packages, and other regulatory dossier) as needed.
• Other duties as assigned.

Qualifications

• Ph.D. in organic chemistry or related field, with a minimum of 5‚Äì8 years of hands-on experience in pharmaceutical, biotech laboratory, or CDMOs. Master‚Äôs with 13 years or Bachelors with 15 years may be considered.
• Strong background in organic synthesis, reaction mechanisms, and crystallization techniques.
• Extensive experience conducting chemical reactions as a process chemist, with understanding of laboratory design for commercial route development.
• Familiarity with scale-up principles and pilot-plant operations.
• Knowledge of PAT and QbD.
• Proficient in scientific software (e.g., ChemDraw, MATLAB, or similar).
• Experience with analytical techniques (HPLC/UPLC) and solid-state characterization tools (DSC, TGA, DVS, XRPD, microscopy, etc.).
• Knowledge of cGMP requirements and regulatory guidance (FDA, ICH).
• Excellent written and oral communication, including drafting and reviewing technical documents and presenting data to peers, management, and external partners.
• Ability to work in a goal- and team-oriented setting with competing priorities.
• Flexibility in a rapidly changing environment with high attention to detail.
• Strong organizational skills and ability to thrive under pressure.
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project).

Skills

• Organic synthesis
• Process development and scale-up
• DoE and process optimization
• Regulatory compliance (cGMP, ICH)
• Technology transfer
• Analytical methods and instrumentation
• Technical documentation
• Cross-functional collaboration

Education

• Ph.D. in organic chemistry or related field (required per above).

Additional Requirements

• Travel up to 10% of time.