About the Role
Our client is a dynamic pharmaceutical company committed to developing life-changing medicines. We are looking for a highly motivated and experienced Senior Process Chemist to join our fully remote drug development team. This critical role involves the design, optimization, and scale-up of synthetic routes for active pharmaceutical ingredients (APIs) and intermediates. You will leverage your expertise in organic chemistry and process development to ensure the efficient, safe, and cost-effective production of high-quality pharmaceutical compounds. This is an exceptional opportunity for a seasoned professional to contribute to critical drug development programs in a remote-first, collaborative setting. If you are passionate about advancing pharmaceutical manufacturing and thrive in an environment that values innovation and scientific excellence, this role is for you. You will play a key role in bringing novel therapies to patients worldwide.
Key Responsibilities
- Design and develop robust, scalable, and economically viable synthetic processes for APIs and key intermediates.
- Optimize reaction conditions, purification methods, and isolation procedures to maximize yield, purity, and throughput.
- Perform process hazard assessments and implement safety controls to ensure safe operations.
- Conduct process validation studies and support regulatory filings (e.g., IND, NDA).
- Troubleshoot and resolve process-related issues encountered during development and manufacturing.
- Utilize Process Analytical Technology (PAT) and Quality by Design (QbD) principles in process development.
- Collaborate effectively with medicinal chemists, analytical chemists, engineers, and manufacturing personnel.
- Author technical reports, development protocols, and relevant sections of regulatory submissions.
- Stay abreast of industry trends, new technologies, and regulatory guidelines in pharmaceutical process chemistry.
- Mentor junior chemists and contribute to a culture of continuous improvement.
Requirements
- Ph.D. or M.S. in Organic Chemistry, Process Chemistry, or a related field.
- Minimum of 6 years of experience in pharmaceutical process chemistry, focusing on API development and scale-up.
- Strong understanding of synthetic organic chemistry principles and reaction mechanisms.
- Proven experience in optimizing chemical reactions, crystallization, and isolation techniques.
- Knowledge of regulatory guidelines (e.g., ICH, FDA) relevant to API manufacturing.
- Familiarity with process safety assessment and risk management principles.
- Excellent problem-solving, analytical, and critical thinking skills.
- Strong written and verbal communication skills, with the ability to effectively document and present technical information.
- Ability to work independently and manage multiple projects in a remote environment.
- Experience with DoE (Design of Experiments) and QbD principles is highly desirable.
Benefits
- This fully remote position offers excellent flexibility and the convenience of working from home.
- Our client provides a highly competitive salary, comprehensive health, dental, and vision insurance, and a generous retirement savings plan.
- We support continuous professional development through internal training, external courses, and conference attendance.
- You will have the opportunity to work on impactful drug development projects that have the potential to improve patient lives globally.
- Enjoy a collaborative and innovative work environment with a team of dedicated professionals.
- Our client is committed to fostering a positive and supportive remote work culture, ensuring excellent work-life balance and employee well-being.