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
Process Streamlining
Global Regulatory Submissions
Superior Written and Oral Communication Skills
Project Management
Conflict Resolution
Standard Operating Procedure (SOP) Management
Professional and Spiritual Counciling
Accomplishments
- 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.