Job Description
Join BioInnovate Therapeutics, a leader in cutting-edge drug development, as we revolutionize pharmaceutical manufacturing. We seek a dynamic Senior Pharmaceutical Process Engineer to optimize production processes and ensure compliance with FDA regulations. You'll collaborate with cross-functional teams to scale manufacturing technologies and drive innovation in biologics production.
Our Boston headquarters offers state-of-the-art facilities and a culture of scientific excellence. Enjoy competitive benefits, professional development opportunities, and the chance to impact patient lives through breakthrough therapies.
Responsibilities
- Design and optimize pharmaceutical manufacturing processes for biologics and small molecules
- Implement GMP standards and ensure FDA/EMA compliance in all operations
- Lead process validation studies and continuous improvement initiatives
- Collaborate with R&D to transfer lab-scale processes to commercial production
- Analyze process data to identify bottlenecks and implement cost-saving measures
- Mentor junior engineers and provide technical guidance to production teams
Qualifications
- Master's degree in Chemical Engineering, Pharmaceutics, or related field (PhD preferred)
- 5+ years of experience in pharmaceutical process engineering
- Expertise in bioreactor design, downstream purification, and formulation technologies
- Strong knowledge of cGMP, QbD principles, and regulatory requirements
- Proficiency with process simulation tools (e.g., SuperPro Designer, gPROMS)
- Excellent problem-solving skills and ability to work in fast-paced environments
- Experience with tech transfer and scale-up operations