Manufacturing Quality

Antonio A. Souto Melgar

***, ********** *********, *** **** Carolina, Puerto Rico 00987-2321

Telephone: (787) 299 - 5097

e-mail: *******-*****-******@*******.***

Linkedin Profile: https://www.linkedin.com/in/antonio-souto-b3098527

Summary of Qualifications

Highly qualified chemist with experience in Oral Solid Dosage, Parenterals Manufacturing, Quality Control Laboratory, Quality Operations Technology Transfer, Analytical Development and Manufacturing Technology. Solid background in process validation, analytical methods development, validation and transfer. Broad experience in Laboratory and Manufacturing high complexity investigations. Strong knowledge in quality systems, pharmaceutical technology processes and process excellence (Lean Six Sigma). Ample exposure and experience to FDA, EMA, ANVISA and Corporate inspections. Excellent ability to manage multiple priorities in a timely manner and demonstrated leadership skills, especially in transforming operations to increase productivity and efficiencies. Ability to communicate across all levels of the organization. Languages: Fluent in Spanish and English. Computer literate.

Professional Experience

Teva, Allergan-Actavis (Warner Chilcott) Fajardo, Puerto Rico

Pharmaceutical Technology Specialist III

Manufacturing Science and Technology Jul 2012 – Jun 2020

Perform review of R & D documentation relating to formulas and processes to acquire the technical knowledge of products being transferred or introduced (Pharmaceutical Data Sheets, Comprehensive Summaries, historical reviews, validation reports NDA’s, ANDA’s, PCS’s and APR’s).

Perform evaluation of processes for new or transferred products and, in conjunction with applicable Process Development or Technical Services groups, preparation of pilot of scale up manufacturing instructions that are valid, efficient and suitable for stability studies.

Analyze stability and analytical history in a timely and effective manner which allows proper responses to any problems that may develop and implement corrective actions.

Carry out process optimization studies and plans to improve products quality and process efficiency and notify management of any cost reduction or avoidance as a result of the exercise.

Compile and issue all the necessary documentation associated with pharmaceutical technology activities (such as batch record, Change Controls, protocols, reports and product summaries).

Perform evaluation of new process equipment and abreast of innovative equipment/processes and their application to the pharmaceutical processes. Become familiar with all production equipment in the pharmaceutical operations.

Advise management about areas of opportunity in the application of novel technologies or materials. Identification of problem areas in formula and processes.

Coordinate of facility, system, equipment qualification, process validation and cleaning validation efforts of a multidisciplinary team.

Provide technical assistance in analyzing manufacturing problems of complex nature by means of manufacturing investigations, process validation reviews, product trend review and root cause analysis.

Design and carry out experimentation to collect data to solve manufacturing problems and recommend a course of action to management and identify alternatives.

Generation and support of Manufacturing Investigation Reports, CAPA and Change Controls. Sustainable in the implementation of corrective and preventive actions in the manufacturing area.

Coordinate and execute cleaning validation, process validation, product transfer and pharmaceutical technology activities. Prepare and issue protocols and reports.

Provide technical input for on-the-job training on new or improved manufacturing process or equipment.

Provide consultation to Training, Manufacturing and Engineering Groups on correct manufacturing instructions or equipment set up to assure that product complies will all applicable standards. Assists such groups in the preparation of SOP’s.

Provide review and audit of validation reports documentation to assure integrity of data, accuracy and compliance with Validation Protocols.

Act as advisor or consultant to the manufacturing personnel concerning manufacturing and cleaning processes.

Analyze data and prepare reports of weight variables distribution estimates for use in design studies.

Pfizer (Wyeth) Carolina, Puerto Rico

QC Scientist II, III, IV

Technology Transfer Laboratory/Analytical Development Jun 2003 − Jul 2012

Ensure product quality attributes through performing chemical tests like: Residual Solvents, pH, TOC, Content Uniformity, Conductivity, Moisture, ID, Completeness and Clarity, Color, Assay, Impurities and Related Compounds, USP/BP/EP Limits Tests and Visual Inspections for In-process, raw materials (Active Pharmaceutical Ingredients & Excipients), finished goods, stability, validations, retentions, cleanings and complaints samples (as applicable).

Generation and support of Laboratory Investigation Reports, CAPA and Change Controls. Sustainable in the implementation of corrective and preventive actions in the laboratory.

Handle, develop and coordinate analytical methods validation and improvement, method transfers, along company sites.

Assist in technical services and manufacturing processes validations and qualifications.

Coordination of personnel (4 QC Scientists) and tests scheduling for raw materials (Active Pharmaceutical Ingredients & Excipients), finished goods, stability, retentions and complaints samples (as applicable).

Coordination of personnel (6 QO Scientists) and tests scheduling for In-process, validations, cleanings and analytical methods validation, improvement and method transfers.

Completed the analytical method transfer to support the submission of the NDA for a key product in over 10 countries.

Optimized laboratory processes using the Operational Excellence concepts like: Lean lab; reduced testing program, analytical method optimization, method improvement and new technologies.

Formulation studies leading to development of enhanced stability of parenteral product.

Development of in-process controls (IPCs) to determine the forthcoming steps needed to be performed for the manufacturing process of a parenteral product.

Lead the product analytical activities and compliance issues around the world supporting other sites and suppliers on critical events, regulatory observations, special studies, method improvements and technology transfers.

Create and deliver training of changes in standard operating procedures and best practices.

Provide mentorship to a group of associates in areas of expertise.

Promote and reinforce a safety environment and Good Laboratory Practices.

Document, review and approve laboratory records through Labware LIMS, QALASS or controlled forms. Manage technical and analytical method reports.

Conduct sampling and logging processes for finished (Quality Control Laboratories) and retention samples using Labware LIMS, SAP or controlled forms as applicable. Gathering, approve and evaluate stability trends and raw data.

Assist and conduct laboratory equipment Installation, Operational and Performance Qualifications (IQ/OQ/PQ).

Conduct laboratory reagents and equipment purchases.

Other duties: Exposure and support in internal, regulatory agencies, environment safety health department and corporative audits. Laboratory logbook coordinator including controlled forms generations and record retention processes. Acting Supervisor as needed.

Bioprocess Scientist

Technical Services Jan 2003 − May 2003

Experience in the re-qualification of manufacturing equipment (Ovens and Autoclaves using KAYE).

Bioprocess Scientist

Manufacturing June 2001 − Dec 2002

Biotechnology based production facility startup.

Formulation scale-up of drug-linked monoclonal antibody, anti-CD33 mAb conjugated to calicheamicin.

Generation of SOPs for production equipments and MBRs for the manufacturing operations.

Generation and support of Manufacturing Investigation Reports, CAPA and change control.

Experience in the qualification of bioprocess manufacturing equipment (Chromatography Skid,

and formulation reactors).

Skills

Fully Bilingual (Spanish - English), written and spoken.

Self-starter, team player, multi-tasking.

Strong Analytical Skills for Problem Solving, Root Cause and Risk Analysis.

Excellent interpersonal skills, adaptable and flexible.

Ability to work under time and work load pressure.

Ability to motivate and/or supervise the activities of others.

Verbal communication skills including negotiation and conflict resolution.

Strong technical writing skills.

Experience in generating and developing documentation like Technical Reports, Technical Assessments, Quality Risk Assessments, White Papers, Validation and Transfer Waivers, SOPs, Manufacturing and Laboratory Investigation Reports, Process Performance Qualification Protocols and Reports (Stage II and III), Annual Product Review, Critical Processing Parameters Documents and Continuous Process Verification reports.

Experience in the generation of documentation to answer EMA Type II Variation Follow Up Measures.

Experience in the generation of documentation to answer FDA 483 observations,

Skills in the design and performance of scientific experiments and interpretation of results.

Computer Literate, experience in handling operating systems like, VMS, Unix, Windows NT, 2000, XP, Vista, 7, 8 and 10 as well as with MS-Office applications.

Experience in handling MS-Sharepoint.

Expierience in handling Minitab.

Experience in handling JMP.

Extensive experience in handling QALASS (controlled forms system) and LIMS (SQL and Labware).

Experience in handling interphase software for Instruments like Agilent HPChem (GC) and Waters Empower in Citrix Environment (HPLC and GC), Varian WinUV (UV-Vis), Perkin Elmer WinLab32 (ICP-OES).

Extensive in handling EQMS (TrackWise and SAP) and EDMS (GxPharma and SCORE).

Qualified Analyst, well trained in the use and qualification of analytical laboratory instrumentation, like HPLC, GC, FT-IR, KF, UV-Vis and ICP-OES.

Knowledge and experience in handling documentation like NDA, ANDA, CMC and R&D Reports.

Project Management Skills.

Trained in Process Excellence (Lean/Six Sigma) tools and concepts at green belt level.

Participation in FDA audits and involved in answering 483 observations related to QC lab issues.

Achievements

Successful transfer of key product method validations which was timely approved for the launch.

Full Evaluation of validation and transfer documents (gap analysis) using the current ICH guidelines and requirements to support the launch and registration of products in US and EU markets.

Academia Research and Development

1998 – 2001: University of Puerto Rico, Mayagüez Campus-Chemistry Department,

Natural Products Laboratory.

Optimization of Bioproduction and Biosynthesis of Essential Oil of

Medicinal Plants.

Cell Tissue Culture of Tropical Medicinal Plants.

Extensive experience in extraction, separation, isolation and characterization of terpenoids.

Extensive experience with use of GC-MS, GC-FID, HPLC-PDA, NMR with 2D modes (COSY and HETCOR), FT-IR and optical rotation for the characterization of isolated medicinal plant components (terpenes).

1993 – 1998: University of Puerto Rico, Mayagüez Campus-Chemistry Department,

Natural Products Laboratory.

Cell Tissue Culture of Tropical Medicinal Plants.

Trained In Aseptic Techniques in Clean Room Environment.

Education

1998 – 2001: University of Puerto Rico, Mayagüez Campus.

Master in Sciences, Chemistry, area of Natural Products.

1993 – 1998: University of Puerto Rico, Mayagüez Campus

Bachelor in Science: Chemistry. Cum Laude Award.

Trainings and Certifications

Colegio de Quimicos PR State Department Chemist License (#4669)

CAPA System Expert Certification(Business Excellence Consulting, Inc)

Lean-Six Sigma Green Belt Training (Rath & Strong Division of Aon Consulting)

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