Licensed Chemist - Quality & Validation Specialist

Urb. Ext. Valle Alto, **** Calle Prados

Ponce, Puerto Rico 00730-4147

Day/Night Tel 939-***-****

Email: *********@*****.***

Nelson Montalvo Rivera

Career

Profile

Results oriented licensed chemist with progressive and diversified technical experience in quality control, process control, technical services, medical devise and environmental laboratory in demanding fast-paced industrial settings. Substantive knowledge of manufacturing operations of oral solid dosage, parenterals and API’s products. Self-starter with demonstrated ability for analyzing data to detect deviations and inconsistencies as well as to interpret sampling test results. Confirmed expertise in problem solving and root cause analysis methodologies. In-depth knowledge of specialized laboratory instrumentation. Strong knowledge of relevant cGMPs, GLP, SOP, LIMS (Empower), writing reports and validation protocols cleaning validations, managed change controls, method transfers and development, Write and execute qualification protocols (IQ,OQ, PQ) FAT/SAT based on established validation procedures, Write and test approvals of Qualification Summary Reports, HAZMAT, HAZWOPER, DEA, FDA, USP/NF, DEA regulations as well as their application. Proficient in Trackwise, CAPA, LIMS, Project Management, EDMQ and SAP. Major strengths in interpersonal and communication skills establishing and maintaining positive working relationships with individuals at all levels using negotiation and coaching talents. Fully bilingual technical writer.

Major Accomplishments

Generated annual cost savings of approximately $10,000 after streamlining EPA methods 524.2, 3695, and 1666 into one method using EPA guidelines and QA criteria reducing total analysis time from two (2) weeks to three (3) days including full peer reviewed report. Revised method 1666 was adopted stateside.

Assumed full responsibility for all Environmental Technical Services operations and systems after company reorganization that involved transfer of two (2) technicians and (2) chemists. Provided accurate analytical services and equipment troubleshooting uninterruptedly to areas including Quality Control Lab, In-Process, and Manufacturing Science and Technology Labs on a 24/7 basis.

Lowered concentrations of active ingredients of Zestril and Atenolol in site’s waste water to comply with Environmental Lab’s Aquatic Exposure Guidelines using Liquid Chromatography Mass Spectroscopy.

Increased yield in synthesis of active ingredient Dipyradamole from 60% to 75% by establishing a procedure to recover mother liquors as well as to recrystallize and purify active ingredient increasing product recovery through experimentation.

Automated chemical synthesis of tetrachlor to dichlor improving reactant’s yield and safety by completely eliminating dangers of corrosive chemical exposure and increasing synthesis safety.

SKALAR Pharma LLC Guayama, Puerto Rico Nov 2022 to Jan 2025

Senior Chemist

Achievements:

Autonomously performed research and development activities and recognized exceptions to normal chemical trends.

Guided new employees on chemical compliance and lab safety by understanding key regulatory organization and policies.

Championed development of new technologies and products which contributes to long term technology and business vision.

Directed projects by evaluating project risks and assessing what is appropriate, reasonable, timely, and realistic.

Managed the scale up of products from the lab bench scale to full scale commercial batches.

Developed all necessary technical documentation to facilitate scale up.

Provided on-site technical support for all piloting and commercial batches.

Coordinated with QC staff to ensure methods and procedures are established and produce the desired results.

Developed the supporting the formulation and equipment and analytical laboratory qualification, IQ/OQ/PQ meeting with all regulatory requirements (FDA, DEA).

AMGEN Juncos, Puerto Rico May 2017 to June 2019

Specialist QC

Achievements:

Wrote and implemented Container Closure Integrity Physical test protocol and report.

Wrote and validated Bioburden and Isoform methods using gels and densitometers.

Wrote and validated Capillary Electrophoresis methods and trained laboratory personell in the use and operation of equipment.

Wrote and validated analytical method Isoelectric Focusing of EPO in Thin Layer Polyacrylamide Gels

Actavis Inc. Manati, Puerto Rico April 2014 to April 2017

QC Analyst

Achievements:

Developed and trained fellow co-workers in SOP for the implementation of the FT-IR spectrophotometer so HDPE bottles and closures could be analyzed internally contributing savings in time and budgeted activities.

Gave support in cleaning validation activities by executing cleaning protocols for CIP 300 and active ingredients, executing analysis in a timely matter avoiding investigations and manufacturing operation down time.

Gave support to analytical methods validation, dissolution, content uniformity, assay and residual solvents (GC).

Professional

Experience

Lilly del Caribe, Inc.

Guayama, Puerto Rico

June 2005 – February 2014

Sr. Environmental Technical Service Representative

Achievements:

As part of an Energy Conservation Project, Relocation of the Organic Section analytical instrumentation from Building 81 to Building 10 in PR06, performed utilities and space requirements, movement, installation qualifications, operation qualifications, performance qualifications, writing IQ, OQ, PQ protocols and final validation reports for Analytical Balances Mettler AT200 and AT2610, GC Hewlett Packard 5890A Series II, HPLC Hewlett Packard 1100 ALS, Agilent 6890 Series GC System, Agilent 6890 GC with Mass Spec 5973N, UV Spectrophotometer Carry 50.

Reduced annual electricity costs by $60,000 by transferring organic section of Environmental Technical Services Lab without affecting Solvent Recovery Process, Tank Farm, and Production Activities.

Identified gaps between Procedures vs Practices on MFG areas. Created Process Maps (Flowcharts), Created Revised SOP procedures and forms. Delivered training to affected personnel on new SOP’s.

IPR Pharmaceuticals Inc.

Guayama, Puerto Rico

March 1997- May 2005

Environmental Laboratory Supervisor

January 2001 – May 2005

Achievements:

Administered a $3M budget to purchase equipments, ICP’s, GC/MSD, LCMSD, TOC, LACHAT IC, Calorimeter, UV/VIS Spectrophotometers, CETAC Mercury Analyzer, Karl Fisher Titrator, and LIMS (StarLims) by performing FAT’s writing and executing IQ, OQ and PQ protocols and validations reports also by writing and validating and consolidating analytical methods.

Purchased a Mobile Environmental Laboratory (Canovanas Site), made site assessment for location and installation, performed IQ, OQ, and PQ to Metromh Karl Fisher Apparatus, Agilent HPLC 1100, pH meters and HACH Field Automatic Auto sampler equipment.

Distributed environmental analytical sampling and testing ensuring maximum use of resources.

Environmental Chemist I

January 1999 –January 2001

Achievements:

Performed groundwater sampling and analysis by current EPA methods.

Executed development, implementation, revision, regulatory validation, validation protocols, and final reports of procedures to comply with local and federal regulations.

API Chemist I

January 1998 – January 1999

Achievements:

Maintained general inventory and purchased equipment, reagents, and glassware.

Provided analytical support to other departments.

ASG Chemist I

March 1997 – January 1998

Achievements:

Performed method validations, method transfer, and chemical plant validation as well as other special tests.

Wrote, implemented, and reported validation protocols, method transfers of API’s and Parenterals and troubleshot analytical and instrumentation problems.

Pontifical Catholic University of P.R., Ponce, PR

Bachelor’s of Science Degree, Major in Chemistry

Puerto Rico Chemist License No. 2936

Education

Selected

Trainings

Certified QA Analyst, Janssen, Titusville, N.J.

Analytical Problem Solving For Chemists, Carolina, PR

Mass Spectral Interpretation, Somerset, N.J.

Problem Solving In the Chemical Laboratories, Guayama, PR

Practical LC/MS, New Orleans, Louisiana

Computer Validation, New Orleans, Louisiana

StarLIMS V9-iPR System Training Course, Hollywood, Florida

LC/MSD Advanced Applications and Operation, North Carolina State University, Raleigh, NC.

Professional Associations

Puerto Rico Chemist’s Association

American Chemical Society

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