Job Description
Join BioPharm Innovations Inc., a leader in cutting-edge pharmaceutical development, as we pioneer next-generation therapies. We seek a Senior Pharmaceutical Process Engineer to drive innovation in our Boston R&D facility. This role offers competitive compensation, comprehensive benefits, and the opportunity to impact global healthcare. If you're passionate about scaling life-saving treatments and thrive in a collaborative, science-driven environment, we invite you to apply.
Responsibilities
- Design, optimize, and validate pharmaceutical manufacturing processes under cGMP standards
- Lead cross-functional teams in process improvement initiatives for biologics and small molecules
- Develop and execute process validation protocols ensuring regulatory compliance
- Investigate and resolve manufacturing deviations through root cause analysis
- Implement lean manufacturing principles to enhance efficiency and reduce costs
- Collaborate with quality assurance on CAPA systems and regulatory submissions
- Mentor junior engineers and provide technical guidance on process technologies
Qualifications
- M.S. or Ph.D. in Chemical Engineering, Pharmaceutics, or related field
- 8+ years of experience in pharmaceutical process development/manufacturing
- Expertise in process validation, PAT, and QbD methodologies
- Strong knowledge of FDA/EMA regulations and cGMP requirements
- Proven track record in scaling processes from lab to commercial production
- Experience with bioreactor, filtration, and chromatography systems
- Excellent problem-solving skills and project management abilities
- Strong communication skills with technical and non-technical stakeholders