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Summary of Qualifications

Experienced professional for Science, Innovation, Quality, Manufacturing and Technology Areas
Pharmaceutical (Active Pharmaceutical Ingredient - API and Drug Product - DP), BioPharmaceutical / Downstream Process to Drinking Water (Purification, Filtration & Detection)
and Medical Devices Industries.
Resilient life sciences professional aligned to quality and results, driven by six sigma and lean

JV
Jaime Vaquer
17348 Radcliffe Place Dr.
Eureka, MO. 63025
(787) 226-3888

manufacturing philosophies. Subject matter expert (SME) for Pharmaceutical (Active


Pharmaceutical Ingredient - API and Drug Product DP, Liquid and Solids Forms), BioPharmaceutical (Collagen Downstream Process, Filtration Technologies, Process Separation &
Characterization, Packaging & Sterilization), Medical Devices and the Drinking Water Facilities
industries including but not limited to Online Equipment Monitoring using process Analytical
Technologies-PAT.

Enthusiastic and motivating professional whom likes to identify opportunities and recommends
new technologies from development to commercialization (Product Lifecycle) with excellent
business sense and full accountability of projects.
Strong knowledge on regulations CFRs parts 210 & 820 and ISO Standards 13485, 9001, 14644,
11137 for a high volume manufacturing and Procedural Standards for Certified Testing of
Cleanrooms National Environmental Balancing Bureau (NEBB).
Upgraded, improved programs and processes through multidisciplinary project team management
Led, prioritized and handled multiple simultaneous tasks to facilitate and resolve cross functional
activities using project management analytical problem solving techniques, including international
experience
Trained Students, Scientist and Engineers to a director level.
Supervised, led, direct initiatives, Process/Product Development, Technical Transfer, Validations
teams, QA, Process Engineering teams, Manufacturing and Business/ Product Strategy;

Process/Product
Development (Bio &
Chemical)

Manufacturing,
Engineering and
Technical Management

Process Development and


Optimization

Project Management

Validation
(Commissioning, IQ, OQ,
PQ, PPQ)

Equipment
Design/Optimization

Risk Assessments

Prototype Development

Product/Process
Technical Transfer

jvaquerm@gmail.com

People
Development

Quality Assurance
Regulatory Compliance
CMO Auditing

NSF Scientific
Instrumentation
Reviewer

Budgets

Sterilization Co60

Process
Engineering

Cleaning
Process/Programs

Education
University of Puerto Rico, Rio Piedras Campus
Ph.D. in Organic Chemistry
Organometallic Synthesis / Molecule Characterization and Quantitation
University of Puerto Rico, Rio Piedras Campus
B.Sc. with concentrations in Chemistry and Mathematics

Publications
6 Publications - Global Scientific Technical Journals, available upon request

Certifications/Trainings
Project Management Course- PMI St. Louis Chapter, MO
Biotechnology-Biochemical Principles and Techniques Certified
Postgraduate Course in Hands-on Tablet Technology - Certified

JV Life Sciences Professional

Certifications/Trainings Cont.
Process Flawless Execution (PM)
Process Excellence (Six Sigma Black Belt, Lean Manufacturing) - Certified
Process Analytical Technology - Certified
Total Quality Management - Certified
Chemical Engineering and Process Fundamentals - Certified
Management Development
Plant, Process and Laboratory Validation- Certified
Quality Assurance-Certified

JV
Jaime Vaquer
17348 Radcliffe Place Dr.
Eureka, MO. 63025
(787) 226-3888
jvaquerm@gmail.com

Some Career Positions Hold


Scientific, Innovation and Technology Consultant (Chemistry, Physics, Microbiology, Engineering,
Compliance, Validation, Technical Transfer, Project Management)
Product Strategic Director
API / Parenteral/Bulk Manufacturing Director
Regional Development Director
Technical Support/PM Technical Transfer Lead and Regulatory Manager
QA Formulation Manager/QA Validation Manager
Sr. Technical Transfer Lead/Sr. Project Manager/Sr. Development Scientist, Sr. Process Engineer
and QA Sr. Engineer

Accomplishments
Audited CMOs for Technical Transfer, remediated gaps and lead the downstream
biopharmaceutical process development for the sterile manufacturing process, form design changes
to commercialization.
Contributed over $30 MM in new earnings, savings and cost avoidance for the BMS Company
(2years).
Consolidated and harmonized Technical Support, R&D, Engineering and Operations Groups,
maximizing resources utilization
Obtained for BMS the global improvement of 35% in first pass quality for API manufacturing in
2002-2003.
Managed budgets of $ 28 MM with positive variance and defend budgets of $325 MM for Global
Development groups
Provided over two millions savings on formulation projects by development, purification, improving
yields, reduced waste, area consolidation, developing and implementing new analytical in-line test.
Lead and support several Process and Product transfers including the Single Use System Business
from Covina, CA. to Pall Life Sciences, Fajardo, PR. (per schedule and in budget). Additional project
includes Areas Design, Commissioning, Productions Lines for API and Drug Product, Packaging
Lines (Solid and Liquids) and Sterilization for all products required by the client.
In charged of design, project management, area qualification, process validations and transfer to
manufacturing of a new formulation suite (ahead of schedule and in budget).
Scheduled, Developed and implemented the global cleaning guidelines and procedures for API/Drug
Substance and Sterile Filling manufacturing.
Hired, developed and managed new and experienced candidates/professionals.
Monitored, scheduled, prepared and implemented the new strategy for site lean operation
(includes CBT for personnel and optimum product portfolio).
Evaluated, improved and developed several Drug Substances/Intermediates and transferred to
Manufacturing facilities.
Negotiated and audited CMOs for aseptic and non-aseptic processing
Taught Science at College and supported new entrepreneurs. Including characterization of
materials, products and impurities (using NMRs, HPLC Mass Spectroscopy, IR, SEM, etc).
Simplified process improvement process for organizations.

Recognitions
Recipient of Johnson and Johnson Standard Leadership Award
Bristol Myers Squibb Technical Operation Presidential Award
SmithKline Beecham World Wide Technical Operation Award
Pall Life Sciences Exceeding Team Performance Award
Cordis, LLC Team Excellent Award

JV Life Sciences Professional