About the Role
Our client, a pioneering pharmaceutical company, is seeking an experienced and visionary Lead Chemical Engineer to spearhead process development and optimization efforts for their innovative drug manufacturing operations. This senior role, based remotely but requiring occasional travel to their facility near Centurion, Gauteng , will play a critical part in scaling up new pharmaceutical products from lab to commercial production. You will be responsible for leading a team of engineers, driving process validation, ensuring Good Manufacturing Practices (GMP) compliance, and implementing cutting‑edge technologies. The ideal candidate will possess a strong background in pharmaceutical process engineering, sterile manufacturing, and regulatory requirements. This is an exceptional opportunity to shape the future of pharmaceutical production and contribute to life‑saving advancements. You will be expected to demonstrate leadership, technical acumen, and a commitment to quality.
Key Responsibilities
- Lead the design, development, and validation of chemical processes for pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs).
- Manage and mentor a team of chemical engineers, providing technical direction and performance feedback.
- Oversee process scale‑up activities, ensuring successful technology transfer from R&D to manufacturing.
- Ensure strict adherence to GMP, FDA, and other relevant regulatory guidelines throughout all process stages.
- Develop and implement robust process control strategies and automation solutions.
- Conduct thorough process hazard analyses (PHAs) and risk assessments.
- Collaborate with cross‑functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure project success.
- Drive continuous improvement initiatives to enhance process yield, purity, and efficiency.
- Prepare detailed engineering documentation, validation protocols, and reports.
Requirements
- Master's degree or PhD in Chemical Engineering or a related field.
- Minimum of 10 years of experience in chemical process engineering, with at least 5 years in the pharmaceutical or biotechnology industry.
- Proven experience in GMP manufacturing environments and sterile processing is essential.
- Demonstrated experience with process scale‑up, validation (IQ/OQ/PQ), and technology transfer.
- In‑depth knowledge of pharmaceutical regulatory requirements (e.g., FDA, EMA).
- Experience with process simulation software and advanced data analytics.
- Strong leadership, project management, and team‑building skills.
- Excellent written and verbal communication abilities.
- Ability to travel occasionally to the Centurion, Gauteng facility as needed.
Benefits
- Our client offers a highly competitive executive salary and bonus structure, commensurate with the seniority and impact of this role.
- A comprehensive benefits package includes premium health, dental, and vision insurance, a generous 401(k) matching program, and stock options.
- We are committed to fostering professional growth through extensive training, conference attendance, and opportunities for leadership development.
- This is a remote‑first position, offering flexibility, with occasional travel to our state‑of‑the‑art facility near Centurion, Gauteng .
- We provide a supportive, innovation‑driven culture where your contributions are recognized and valued.
- Generous paid time off and holidays are standard.
- Join us in making a significant difference in global health.