Job Description
Join NovoMed Therapeutics, a cutting-edge biopharmaceutical leader, as we revolutionize drug delivery systems. We seek a visionary Senior Pharmaceutical Process Engineer to drive innovation in GMP-compliant manufacturing. You'll lead process optimization initiatives for injectable biologics, ensuring scalability and regulatory excellence while mentoring a world-class team. This role offers unparalleled opportunities to shape the future of pharmaceutical manufacturing in a collaborative, research-rich environment.
Responsibilities
- Design, validate, and optimize upstream/downstream bioprocessing workflows for monoclonal antibodies
- Lead cross-functional teams in implementing continuous manufacturing technologies
- Ensure compliance with FDA, EMA, and ICH Q7 guidelines through robust process validation
- Develop PAT (Process Analytical Technology) strategies for real-time quality monitoring
- Mentor junior engineers while establishing best practices for risk assessment (FMEA)
- Drive cost reduction initiatives through lean manufacturing principles
- Represent engineering in regulatory audits and pre-approval inspections
Qualifications
- MS/PhD in Chemical Engineering, Bioengineering, or Pharmaceutical Sciences
- 8+ years' experience in biopharmaceutical process development/manufacturing
- Expertise with single-use systems, chromatography, and viral clearance validation
- Proven track record in tech transfer from lab to commercial scale
- Strong statistical analysis skills (DoE, SPC) using JMP or Minitab
- Certification in GMP or Six Sigma (Black Belt preferred)
- Demonstrated success in leading cross-functional regulatory projects