About the Role
Join our client, a globally recognized leader in pharmaceutical manufacturing, as a Remote Lead Chemical Engineer. This fully remote position offers an exceptional opportunity to drive innovation and excellence in pharmaceutical process development and manufacturing from anywhere in the world. You will play a critical role in designing, scaling up, and optimizing processes for novel drug compounds and existing pharmaceutical products. We are seeking a visionary leader with a deep understanding of GMP regulations and a passion for advancing healthcare solutions. This role requires strong leadership, technical acumen, and the ability to collaborate effectively in a virtual environment. Your expertise will directly contribute to bringing life‑saving medications to market efficiently and safely.
Key Responsibilities
- Lead the conceptualization, design, and implementation of innovative chemical processes for pharmaceutical intermediates and APIs.
- Oversee process scale‑up activities from laboratory to pilot and commercial manufacturing, ensuring robust and reproducible outcomes.
- Develop and validate manufacturing processes in strict accordance with cGMP guidelines and regulatory requirements (FDA, EMA).
- Conduct in‑depth process characterization, risk assessments, and optimization studies to enhance yield, purity, and cost‑effectiveness.
- Manage cross‑functional project teams, including R&D scientists, analytical chemists, and manufacturing personnel, in a remote setting.
- Provide expert technical guidance and mentorship to junior engineers and scientists.
- Author and review critical process documentation, including batch records, validation reports, and regulatory submission sections.
- Troubleshoot complex manufacturing issues, identify root causes, and implement effective corrective and preventative actions (CAPAs).
- Foster a culture of continuous improvement and operational excellence within the global manufacturing network.
Requirements
- Master's or Ph.D. in Chemical Engineering or a closely related field.
- 10+ years of experience in pharmaceutical process development, scale‑up, and manufacturing, with at least 3 years in a lead or supervisory role.
- Extensive knowledge of cGMP regulations and ICH guidelines pertinent to pharmaceutical manufacturing.
- Proven track record in designing and optimizing complex chemical synthesis processes, particularly for small molecules.
- Proficiency with process modeling and simulation tools (e.g., Aspen Plus, SuperPro Designer).
- Exceptional leadership, project management, and communication skills tailored for remote collaboration.
- Ability to work independently, manage multiple priorities, and deliver results under tight deadlines.
- Experience with QbD (Quality by Design) principles and PAT (Process Analytical Technology) is a strong plus.
Benefits
- As a fully remote employee, you will enjoy unparalleled flexibility and autonomy.
- Our client offers a highly competitive salary, comprehensive global health coverage, stock options, and generous professional development allowances.
- You will have the opportunity to work with a world‑class team on cutting‑edge pharmaceutical technologies, contributing to significant advancements in patient care.
- A significant annual bonus is also part of the package.
- Work from your preferred location and make a global impact.