Jaime Vaquer Ph.D., Pex Email & Phone Number

Raleigh, North Carolina, Us

Raleigh, North Carolina, Us

Project Management Commissioning & Qualifications, Technical TransferFacilities Design ReviewQuality System AuditReviewer for ICH12, ISPE Guides C&Q and Technical TransferFrom R&D to Commercialization (API's (B-Lactams and non-B-Lactams), enzymatic process}, Drug Product, Aseptic Processing)API, Drug Product, Combo Products and Cannabis SME

*Microorganism detection for drinking water facilities*CMO's Audit for Aseptic processing *Led the CMO's remediation*Develop the manufacturing process for Collagen (downstream Bio-pharmaceutical) * Led the Technical Transfer process to two CMO's *Led Validation Department (executing all Project Management requirements)*Sr. Development Process Scientist - cleaning support *Filter technology design, validation and manufacturing*Utilities Qualifications*Cleaning Programs*Technical Transfer/Validation of controlled substances and Solid Dosage at Nesher Pharmaceutical Saint Louis, MO - ISPV 2014-2015*Technical Transfer/Validation of Solid Dosage from PR to California - Pharma Bio-Services 2013*Support Clients from R & D to Commercialization *Develop Companies Master Plans *Evaluate and revise Proposal on Science, Innovation and Technology requesting federal agencies funding (SBIR/STTR)*Discuss options on proposals with agencies program managers*Led the information transfer of CiT with Puerto Rico municipalities*Led center initiative to integrate PR agricultural businesses with USDA*Recommended alternatives to inventors in order to achieve better systems thus proposals*Recommended strategies and develop project plans for schedule attainment*NSF reviewer for SBIR Scientific Instrumentation*Clean Room design, product compatibility and commissioning*Prototypes*Business Startups

*Evaluate Scientific and Technological Opportunities for the Organization.*Drinking Water Process Equipment Design/Installation/Commissioning/Validation*Performed Project Management with Cross Functional Team*Instrumentation Design, Development and Manufacturing*Select and Recommend Latest Global Membrane Filtration Technologies *Performed Process Control including on-line TOC,DOC,TTHM's,THM's,....*Represent on-line THM's equipment for drinking water applications

Visionary Leader for the Engineering, Innovation and Scientific Consulting Firm. www.Sytech-IS.com

Bridgeton, Mo, Us

*Led the Validation Department for R&D and Solid Dosage Manufacturing - Commissioning, Equipment IOQ, CSV, Utilities IOQ/PQ, Process Validation, Cleaning Validation*SME for Cleaning Validation Program Development and Implementation

• Led, prepare and perform IP’s, Process Confirmation/Validation, DOE’s protocols and final reports for OTC solid and Control Substance products (Tylenol® & Sudafed®); dispensing, milling/charging, blending, tablet compression (Manesty Elite, Fette), tablet coating (Bohle & Vector) and tablet printing operations.• Review, modify and audit executed protocols and Master Batch Records. • Train manufacturing and process engineering personnel on development phase and process validations. • Prepared protocol, challenged CCP and CQA for process performance exercise

-Business Development-Business Transfer Consultant-Project Management-Development-Quality Control/Assurance-Validation-Manufacturing-Sterilization (Gamma -cobalt 60)-People Development

Miami Lakes, Fl, Us

•Directed the DES formulation, investigations and Technical Transfer teams.•Led multidisciplinary project team and managed an $8 mm project budget.•Served as liaison between corporate technical and local management. •Identified opportunities and negotiated budget for project implementation.•Led the advance technology team at Cordis, San Germán by selecting, evaluating and implementing new equipments.•Developed and implemented analytical testing at the manufacturing floor (new NIR on line). •Evaluated, selected and implemented a PAT device (TruScan) at the receiving inspection area.

•In charge of the API’s facilities (3 building, 7 final processes and 8 intermediates).•Developed and managed a $28 mm API manufacturing budget (positive variance).•Responsible and accountable for bulk planning and logistic to achieve schedule attainment and ship to promise of over 95%.•Responsible for the implementation of a new pilot plan.•Created a bulk strategy production plans.•Best global improvement of 35% in first pass quality for API manufacturing in 2002-2003. •Developed and implemented the global cleaning guidelines and procedures for API manufacturing

•Developed and established the first development team in PR for Bristol Myers Squibb.•Subject Matter Expert responsible of intervening with Regulatory agencies.•Served as a liaison between corporate and local upper management.•Developed, designed and constructed a development laboratory area and one pilot plant with full qualification.•Managed a team of over fifty associates.•Developed steps of two new drugs.•In charge of global technical transfer for Puerto Rico.

As scientist in SmithKline Beecham (SB) I was in charge of Technical Support Team at Guayama plant. The team achieved the fastest product technical transfer for the company and reaches the highest product global yield and quality in 6 months. The team was recognized worldwide in SB.

Ph.D., Chemistry/Synthetic Organic Chemistry/Molecules Separation And Characterization

Bachelor Of Science (Bs), Majors In Chemistry & Mathematics