PHUC NGUYEN
Huntington Beach,CA
Summary
- Experience working in scaling up pharmaceutical projects from preclinical trial scale to commercial stage. Serving as SME in process development, analytical HPLC, cGMP, SOP, MBPR and CMC.
- Lead a Manufacturing team to produce multimillion dollar projects in Drug substance manufacturing / Active Pharmaceutical Ingredients (API) manufacturing under very aggressive timelines and against many constraints while maintaining product quality and complying with safety, FDA and other agencies requirements.
- More than 9 years of GMP manufacturing leadership experience.
- Possess a CAN-DO attitude to complete company financial goals years after years.
Overview
24
24
years of professional experience
Work History
MANAGER
Bachem Americas
09.2021 - Current
- Lead a team of 12-18 chemists/technicians to produce multiple GMP projects as Drug Substance / Active Pharmaceutical Ingredients (API) through all product manufacturing stages, using all resource allocation to ensure smooth operations
- Manage multiple projects which include cross-site tech transfer of Process Chemistry, technical know-how, ensure scalability from preclinical up to multi-kilogram scale with close collaboration with Quality Control(QC), Quality Assurance (QA), CMC and Regulatory Affair for regulatory filings DMF
- Implement and enhance organic chemistry processes to produce an extra $1M over the top line within the first 12 months at the position by resolving technical issues.
- Working cross-functionally with all the internal and external stakeholders to adhere strictly to all GMP compliance, ICH guidelines and ready to be audited by QA, FDA, customers, and other agencies
- Collaborate and Approve SOPs, Master Batch Record (MBPR) and Process Development/Validation Protocol and Tech Transfer Protocol for the manufacturing site
- Present chemical development and process improvement at company and Pharmaceutical Science conferences
TEAM LEAD/SUPERVISOR
Bachem Americas
09.2014 - 01.2021
- Support Manufacturing team with all necessary allocated resources ensuring smooth and stable operation of the Production department. Achieved Process validation of a specific product within 3 months time (vs. 6month to 1 year) to ensure Production's financial goals.
- Draft Technical reports, deviation, Non-Conforming Report and CAPA investigation to comply with cGMP/ICH guidelines, QA standards and FDA regulations
- Author manufacturing protocol including method validation, process challenge
- Propose technical/process improvements of many manufacturing process by working closely with R&D
CHEMIST II
Bachem California Inc
01.2011 - 09.2014
- Take charge of chemical development activities to complete projects on time while attending MBA grad school at night
- Assisting the department management to maintain a stable and predictable GMP manufacturing operation and produce 24 batches within 24 months as planned (vs 1.5month/batch before).
- Successfully executed high number of In Process Control Method Validation for projects.
TECHNICIAN
Dunn Edwards Corporation
01.2010 - 01.2011
- Developing and checking quality of existing and new paint formulas created by chemists.
SCIENCE TEACHER
School of North America, HoChiMinh
08.2008 - 08.2009
- Contributed science background and strong communication skills toward effectively presenting/ instructing American-based science program targeting high school students.
CHEMIST I
Bachem California Inc
08.2006 - 08.2008
- Proficiently synthesized and purified peptides from amino acids for application as Active
- Pharmaceutical Ingredient (API) for pharmaceutical industry, consistently ensuring critical compliance with GMP/ICH guidelines, QA standards and FDA regulations
- Daily routine includes working with pHPLC and all related analytical methods.
MANAGER
Alta Dena Dairy Store
07.1999 - 06.2004
- In recognition of dynamic performance, rapidly promoted from Cashier to manage full-scope store operations, taking annual gross sales to over $1M for 3 consecutive years.
Education
MBA - Finance
California State University - Fullerton
Fullerton, CA06.2013
Bachelor of Science - Biochemistry
University of California - Los Angeles
Los Angeles, CA06.2006
Skills
- Technical Proficiency
- Budgeting and Cost Control
- Contract Development and Management
- Project Management
- Complex Problem-Solving
- Team Leadership
- Cross-Functional Team Management
- Strategic Planning
- Master Scheduling
- Continuous Improvement Process
- Strong Market Sense
- Health and Safety Compliance
- Knowledge of 5S Methodology
Enthusiastic Family Traveler
Enjoy annual family travel trips
Timeline
MANAGER
Bachem Americas
09.2021 - Current
TEAM LEAD/SUPERVISOR
Bachem Americas
09.2014 - 01.2021
CHEMIST II
Bachem California Inc
01.2011 - 09.2014
TECHNICIAN
Dunn Edwards Corporation
01.2010 - 01.2011
SCIENCE TEACHER
School of North America, HoChiMinh
08.2008 - 08.2009
CHEMIST I
Bachem California Inc
08.2006 - 08.2008
MANAGER
Alta Dena Dairy Store
07.1999 - 06.2004
MBA - Finance
California State University - Fullerton
Bachelor of Science - Biochemistry
University of California - Los Angeles
Similar Profiles
Steven RicoSteven Rico
Senior Lab Technician at Bachem AmericasSenior Lab Technician at Bachem Americas
Elaine DananElaine Danan
Quality Control Scientist III at Bachem AmericasQuality Control Scientist III at Bachem Americas
Candice VealCandice Veal
Material Coordinator at Bachem AmericaMaterial Coordinator at Bachem America