Physical training, outdoor activities, traveling, intrigued about studying and teaching the Bible
Kurt Romondt
Senior Pharmaceutical Drug Product, Process Development Engineer
Brook,NY
Summary
Pharmaceutical Engineer with 18+ years of experience in late-stage drug product development in the Pharmaceutical Industry with a strong ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
7
7
years of post-secondary education
4
4
Languages
Work History
Late Stage Drug Product Process Development
Merck Pharmacueticals, Inc.
Kenilworth/Summit, New Jersey
- Researched and developed (10+) drug product manufacturing processes
- Scaled-up and transferred drug product manufacturing processes from R&D to commercial manufacturing sites
- Performed Process Validation (or Process Qualification Performance (PPQ) to confirm reproducibility of manufacturing process at commercial manufacturing sites
- Prepared and filed Chemistry, Manufacture, and Control (CMC) Sections including Process Development Reports to Food and Drug Administration (FDA) and other Global Regulatory Agencies
- Communicate scientific work effectively, with clarity, integrity, and transparency to wide variety of audiences inter and intra department, peer reviewers, and global regulatory agencies
- Developed strong communication and organizational skills through working on group projects
- Applied effective time management techniques to meet tight deadlines in fast-paced environment
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations
Education
Master of Science - Pharmaceutical Engineering
New Jersey Institute of Technology
Newark, New Jersey 01.2003 - 08.2005
Bachelor of Science - Chemical Engineering
New Jersey Institute of Technology
Newark, New Jersey 08.1991 - 05.1996
Skills
Global Clinical Supplies Manufacturing
undefinedAccomplishments
- Successfully developed and brought two new drug products to global market:(1) ezetimibe, first in it's class as an inhibitor of intestinal cholesterol, to treat people with hyperlipidemia; (2) boceprevir, a treatment for chronic hepatitis C in adults, for use in combination with peginterferon-alpha and ribavirin. This combination therapy was the first to increase the sustained virological response (SVR) rate from 40% to 75% in patients with genotype1
- Performed numerous development studies (20+) over a variety of platforms (as discussed in Areas of Expertise)
- Lead technology transfer projects across various manufacturing sites abroad namely: Puerto Rico, Singapore, Canada, including Hyderabad India at Dr Reddy's Laboratories Limited
- Served as part of the Schering-Plough Consent Decree Remediation team throughout 2004-2005 addressing gaps in quality systems in response to FDA decree
- Prepared, reviewed, and defended various Investigational New Drug (IND) applications and New Drug Applications (NDA) for the submission to FDA and other Global Regulatory Agencies
- Supervised and coached junior scientists through the full late stage development process
- Gained strong leadership skills by managing projects from start to finish (~5-7 years project timespan)
Areas of Expertise
Oral Solid Dosage Forms:
- Tableting
- Encapsulation process
- Direct compression
- High shear granulation
- Fluid bed granulation and drying (including Wurster Column coating)
- Film coating technology (immediate and extended release)
In addition proficient in use of:
- Quality by Design
- Six Sigma training
- Quality Risk Management
- Prospective Process Analysis (PPA)
- Statistical Analysis: Design of Experiments (DOE), Statistical Process Control (SPC), Acceptance Quality Limit (AQL) Sampling
- Root Cause Analysis (A3, SIPOC, Fishbone, Kaizen)
- 5S Lean Workplace Pillars
Additional Information
Volunteered as:
Bible study leader, mentor for English as second language, tutor for GED test, served at the New York City Relief Bus, Elizabeth, NJ
Interests
Timeline
Master of Science - Pharmaceutical Engineering
New Jersey Institute of Technology
01.2003 - 08.2005
Bachelor of Science - Chemical Engineering
New Jersey Institute of Technology
08.1991 - 05.1996
Late Stage Drug Product Process Development
Merck Pharmacueticals, Inc.
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