Senior Process Chemist (Multistep Route Development)

Position Summary

Responsible for the design, optimization, and safe scale‑up of multistep synthetic routes to complex small‑molecule β‑keto amines from laboratory to pilot scale. The chemist will lead all chemical aspects of route execution, including reaction design, hazard assessment, work‑up and crystallization strategy, and close collaboration with engineering, analytical, and safety teams in a fully licensed, highly regulated facility. Role will require occasional lab visit paid for by company once a month or once a quarter with travel and stay paid for by company.

Key Responsibilities

• Route design and optimization
• Develop, refine, and document multistep synthetic routes (e.g., ketone → amination → salt formation) with emphasis on yield, robustness, and scalability.
• Design experiments to optimize reaction conditions, solvent systems, and crystallization protocols for consistent product quality.
• Scale‑up and batch execution
• Translate bench chemistry into pilot‑scale batch instructions, including charge order, addition profiles, mixing, and temperature regimes.
• Oversee execution of batches from start to finish, interpret in‑process data, and make real‑time decisions on hold points, re‑work, and progression.
• Safety and hazard management
• Lead reaction‑hazard assessments for halogenation, amination, and acid/base steps; identify exotherms, gas evolution, and incompatibilities.
• Specify engineering and procedural controls for bromine, concentrated mineral acids, amines, and solvent inventories; contribute to HAZOPs and safety reviews.
• Ensure compliance with all internal safety policies and external regulations governing controlled or hazardous chemicals.
• Analytical and quality support
• Work with analytical chemists to define in‑process controls and release tests (e.g., LC‑MS, NMR, HPLC/GC, water/solvent content).
• Interpret analytical results to diagnose impurities, degradation pathways, and batch‑to‑batch variability; propose corrective actions.
• Documentation and regulatory compliance
• Prepare and maintain detailed batch records, SOPs, process descriptions, and change‑control documentation.
• Support regulatory filings and inspections related to handling, storage, and reporting of regulated substances.
• Cross‑functional collaboration
• Interface with engineering, EHS, operations, and QA/RA to ensure processes are safe, scalable, and compliant.
• Mentor junior chemists and technicians in best practices for multistep synthesis and scale‑up.

Required Qualifications

• MSc or PhD in Organic, Medicinal, or Process Chemistry, or closely related discipline.
• Several years of hands‑on experience (post‑graduate) in multistep synthetic route development and scale‑up, ideally including halogenations, nucleophilic substitutions, and crystallization of amine salts.
• Demonstrated competence in reaction hazard and scale‑up safety (e.g., experience with exothermic reactions, calorimetric data, and plant‑ or kilo‑lab‑scale operations).
• Strong working knowledge of analytical techniques (NMR, LC‑MS/GC‑MS, HPLC/GC) and their application to process decisions.
• Familiarity with regulatory frameworks for hazardous or controlled substances (or willingness to undertake specialized training).

Preferred Skills and Attributes

• Prior experience in pharmaceutical or fine‑chemical process chemistry.
• Experience designing and troubleshooting crystallization and solid‑form processes (salt screening, polymorph awareness).
• Excellent written and verbal communication skills for technical reporting and cross‑functional work.
• Strong problem‑solving mindset and ability to work safely under time and throughput pressures.
• Compensation will be determined based on experience.
• This role is open to applicants based in both the United States and Canada.
• Office or on-site work will be required on an as-needed basis, with all travel and accommodation fully covered by the company.

Job Type: Full-time

Work Location: Hybrid remote in Washington, DC 20009