About the Role
Our client, a leading pharmaceutical company dedicated to developing life-saving medicines, is seeking an accomplished Chemical Engineer for a fully remote position. This role is focused on the development, optimization, and scale-up of chemical processes used in the synthesis of active pharmaceutical ingredients (APIs). You will play a crucial part in translating laboratory-scale discoveries into robust, scalable manufacturing processes that meet stringent regulatory requirements. This is an ideal opportunity for a highly skilled engineer with a passion for innovation and a proven track record in pharmaceutical process development to work remotely and contribute significantly to global health initiatives. Your expertise will be essential in ensuring the efficient and safe production of critical pharmaceutical compounds.
Key Responsibilities
- Design, develop, and optimize chemical synthesis routes and manufacturing processes for APIs.
- Conduct process hazard analyses (PHAs) and ensure compliance with cGMP and regulatory guidelines (FDA, EMA).
- Perform process modeling and simulations to understand reaction kinetics, thermodynamics, and mass transfer.
- Oversee pilot plant operations and support the scale-up of processes from lab to commercial manufacturing.
- Troubleshoot process deviations and implement robust solutions to maintain product quality and yield.
- Develop detailed batch records, SOPs, and validation protocols.
- Collaborate with R&D chemists, analytical scientists, and manufacturing teams.
- Write technical reports, process descriptions for regulatory filings, and present findings.
- Ensure all activities comply with environmental, health, and safety (EHS) standards.
- Stay current with advancements in pharmaceutical manufacturing technologies and process analytical technology (PAT).
Requirements
- Ph.D. or Master's degree in Chemical Engineering with a specialization in pharmaceutical process development or organic synthesis.
- Minimum of 7 years of experience in the pharmaceutical or biotechnology industry, focusing on API process development.
- In-depth knowledge of organic chemistry, reaction engineering, and separation technologies.
- Strong experience with process modeling and simulation software relevant to chemical synthesis.
- Proven understanding of cGMP, ICH guidelines, and regulatory submission requirements.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with experience in preparing technical and regulatory documents.
- Demonstrated ability to work independently and manage projects effectively in a remote setting.
- Experience with crystallization, filtration, and drying operations is highly valued.
- Proficiency in statistical analysis and Design of Experiments (DoE).
Benefits
- This fully remote role offers a competitive salary and comprehensive benefits, including excellent health coverage, retirement plans, and generous paid time off.
- Our client provides unparalleled opportunities for professional growth, exposure to cutting-edge pharmaceutical R&D, and the chance to contribute to meaningful therapeutic advancements.
- Work from your preferred location while collaborating with a world-class team of scientists and engineers.
- This position is perfect for a driven Chemical Engineer looking to advance their career in pharmaceutical process development within a flexible, remote framework.