Nayda López Robles
Naguabo
Summary
About ten (10) years of experience in the pharmaceutical industry working with the Quality Operations Department, Quality Control In-Process and Biochemistry Laboratories and Manufacturing Department. Dynamic and compromised team lead with a solid work ethic, committed to excellence and success, searching a career development in a progressive organization that encourages teamwork and provides opportunity for professional growth. Deep technical knowledge of proteins and bio-molecules handling and analysis. Support as coordinator of the logistic for audit activities, project management and facilitate communication within different multifunctional groups. Experience in analytical methods, analytical equipment validations and New Product Introduction (NPI) process. Experience with method remediation's for method improvement as SME for laboratory techniques. Participated in root cause analysis to support laboratory and manufacturing investigations. Experience writing investigations, data integrity assessments, deviations, audit reports and exceptional knowledge in the revision of documentations. Support and own CAPA’s implementation actions and laboratory investigations for In-process, lot release, and stability samples.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Specialist Manufacturing - Process Owner
Amgen Manufacturing Limited
10.2021 - Current
- Ability to communicate and collaborate with technical and management staff within manufacturing, laboratories, process development, and quality.
- Good communications skills (oral and written) and comprehend in English and Spanish.
- Excellent Project management skills, able to develop strategy plans, execute and contribute with others in order to successfully deliver.
- Exceptional organization, technical writing, project management and presentation skills.
- Experience in leading and managing professional teams within the analytical laboratory on the floor and operation support team.
- Initiate, revise, approve and owns manufacturing and laboratory procedures, supporting documentation or protocols.
- Assess process performance by observation of floor operations and the review of performance data.
- Evaluate, plan, and implement solutions for process improvement opportunities.
- Provide troubleshooting support or assist in the evaluation of atypical events in the manufacturing and laboratory areas.
- Assist in generation and revisal of training materials and assist in providing training on scientific or technical aspects of the process to manufacturing and laboratory associates.
- Participate as the primary point of contact for evaluation of compendia changes impact to the site and Method Transfer Activities for new product introduction (NPI).
- Maximize performance by introducing processes and procedures; partner with departments to drive changes.
- In depth knowledge of Laboratory working principles, Good Documentation Practices and Good Laboratory Practices (GDP and GLP).
- Support establishment of process monitoring parameters and control limits.
- Provide support of timely execution of the process monitoring semi-quarterly reports.
- Responsible to support investigation reports, Root Cause Analysis and CAPA identification to avoid recurrence of the events
- Responsible for execution of corrective actions related to the manufacturing and laboratory processes.
- Additionally, responsible for managing and closing Minor Deviations, CAPA and CAPA EVs within established goal.
- Review equipment/system investigations and support trend evaluations.
- Generate, owned, review and participate in Laboratory Investigations: Analytical Result Assessment (ARA).
- Assist with generation and execution of process validation protocols and reports.
- Participate actively in regulatory inspections and Audits providing tours and supporting information, presenting specific topic to auditors among other tasks.
- Participate actively in the New Product Introduction process to assess requirements for documentation, materials, training, and equipment modifications
- Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification and or introduction projects.
- Assist change owners with assessment of impact to the area, revision and approving manufacturing and laboratory documentation.
- Knowledge in the use and application of Pharmacopeias (USP, EP and JP) and skilled in performance of GMP production operations.
- Identified as subject matter expert for pH, Conductivity, Osmolality, Absorbance, Protein Concentration, Appearance, Color and Clarity analytical analysis for biological products and preparation of surface sampling kits for Total or Non Purgeable Organic Carbon (TOC or NPOC) analysis.
- Experience with chemistry laboratory equipment: UV- spectrophotometer, Osmometer, Turbidimeter, pH meter, Instron, analytical balance, among other.
Acting Manager QC NPOC-Water/Wet Chemistry Lab
Amgen Manufacturing Limited
10.2020 - 10.2021
- Designated temporarily to develop the previous experience, but not limited to, as Sr Associate QC at the NPOC/Wet Chemistry Laboratory to lead and manage the professional team of the Second and Third shift, including regular and temporary staff
- Responsible for the Career Development of all the associates and providing direct feedback
- Responsible to establish short- and long-term plans for timely and efficient execution of analytical testing activities within the scope of business priorities, and organize, plan, and schedule individual and collective work
- Participate actively in General Technical Excellence Team (TET) representing QC and completing the Compendial assessment for the laboratories of Wet Chemistry and Raw Materials
- Actively participating with RCA, deviations, investigations, validations, CAPA’s and projects that will help to improve the development of the area
- Also, manage routine UR, OOT’s and/or OOS investigations
- Assured the optimum utilization of laboratory resources equipment and personnel for timely and efficient testing in compliance with regulatory requirements to support company goals and objectives
- Support directly to internal and external Audits, participating and preparing the area for inspection readiness process
- Always driven for results, to help achieve the best team by setting of key asset management strategies for future years.
Sr Associate QC NPOC-Water/Wet Chemistry Lab
Amgen Manufacturing Limited
02.2016 - 10.2020
- Representing QC in SoloVPE Technical Excellence Team (TET) to discuss Protein Concentration methods changes, concerns, invalid assays, and being accountable for actions items generated from those meetings
- Worked directly with the network as QC representant to harmonize protein concentration methods and the implementation of the Solo VPE for protein concentration determinations
- Ability to recognizes, anticipate problems, identify roadblocks to the tasks completion and develop plans to prevent or minimize impact to area goals
- Designated as backup of Lab Manager during his/her absence by making resources allocation, decisions, and recommendations consistent with priorities and business requirements, creating new ideas, delivering results, driving for continuous improvement
- Demonstrating leadership skills by conducting area meetings in order to discuss daily schedules and resolve any daily laboratory issue
- Support FDA inspections as coordinator of the logistic and QC audit activities in support to Amgen Compliance and Quality Assure team
- Participated in method remediations for method improvement and lead as subject matter expert for laboratory techniques
- Responsible to schedule task to the team to comply area goals considering departmental metrics and contributing for the metrics improvement
- Assigned to train analysts, monitor special projects or special studies, responsible of resolve routine common problems and manage routine UR, OOT’s and/or OOS investigations
- Routinely perform maintenance, calibration and use of equipment’s such as Analytical Balances, pH meters, Conductivity Meters, Osmometers, TOC analyzers, SoloVPE Cary 60, Instrons and UV-Vis spectrophotometer
- Associated with technical reports on product, method/product transfer, validation, and execution of protocols and Method’s revisions
- Provide support to Technical Resources department during the method transfer and validations of new methods and products
- Participated in root Cause analysis to support Trend Investigation and being recognized for the support major investigations as method SME
- Responsible to perform and approve analytical testing of In-Process, lot release and stability testing on a daily basis for analysis such as Polysorbate Test, pH test, Protein Concentration, Breaklose and Extrusion (BLE), UV Absorbances, Osmolarity, Refractive Index, Appearance, Volume, TOC, Conductivity, among other Physical and Chemical test methods
- Recognized to support Attribute Sciences by participating as Subject Matter Expert for some laboratories methodologies and contribute with transfers assessments
- Provide support to Validation department with testing and approvals of new laboratory equipment validations
- Present laboratory learning forums to share my experience and knowledge on laboratory techniques and leadership with my peers.
Associate Scientist
Pall Life Science (SLS)
10.2015 - 01.2016
- Understand and execute validation projects using product and model solvents
- Preparation of solutions, buffers and media that are required for the project
- Routinely perform maintenance, calibration and use of equipment’s such as Analytical Balances, pH meters, Conductivity Meters
- Assemble and operation of test apparatus, able of understand and perform troubleshooting
- Manage instrumentation necessary to support testing
- Execute the dissembling and cleaning of the apparatus and instrumentation
- Perform test work according to laboratory request requirements
- Record raw data directly onto datasheets or into laboratory notebook
- Manage any test delays, problems, or deviations, providing immediate notification to laboratory manager and project manager.
QC Associate- EW NPOC-Water/Wet Chemistry Lab
Amgen Manufacturing Limited
10.2013 - 10.2015
- Execute Quality Control release testings’ for in process samples, finished product, drug substance and drug product derived from proteins (large molecules) and chemical process of small molecules, buffers, water samples, cleaning validation samples among others
- Visual analysis of the product
- Preparation of solutions, buffers and media that are required for the analysis of the product
- Interaction with NPOC/TOC equipment
- Perform maintenance, basic troubleshooting, work orders execution and documentation, also analysis of cleanings and daily waters
- Routinely perform maintenance, calibration and use of equipment’s such as Analytical Balances, pH meters, Conductivity Meters, Osmometer, HIAC Royco Particle Counter Systems and UV-Vis spectrophotometer
- Prepare and document analytical test reports and sample issues according to procedures
- Extensive knowledge in data/protocol review, sop revision and documentation form creation
- Assigned to train analysts, set schedule priorities in the lab, monitor special projects or special studies, responsible of resolve routine common problems and manage routine UR, OOT’s and/or OOS investigations
- Associated with technical reports on product, method/product transfer, validation, and execution of protocols.
Education
MBA - Medicinal And Pharmaceutical Chemistry
University of Florida
Florida, US12.2024
B.S. Chemistry -
University of Puerto Rico, Mayagüez Campus
Mayagüez, PR05.2013
Skills
- Exceptional bilingual listener and communicator with great capacity in oral and written communication
- Greatly in analytical thinking with demonstrated talent in order to identify and improve laboratory procedures
- Hands on instrumental method of analysis: UV-Vis 2600 PC Shimadzu, Cary 60 with SoloVPE, TOC Sievers, Breakloose and Extrusion (BLE) Instron Material Tester and other instruments Vast knowledge in laboratory equipment troubleshooting
- Advanced knowledge of computer and process softwares: VIVA - CDOCS, LIMS, Trackwise, LMES (Laboratory Electronic Notebook), CIMS, Maximo, UV LabSolutions, MES, validated spreadsheets, Microsoft Word, Excel, PowerPoint, Internet, corporative web base, systems, and e-mails (outlook) among others
- Acquainted with laboratory procedures such as: GMP’s, GLP’s, GDP’s, SOP’s and other industry specifications and regulations such as FDA and OSHA, including combined products for biological product supplied in a medical device
- Also, well understanding and user of SDS, USP, EP, JP and ACS reference methods, analytical methods, and validation protocols, among others
- Excellent qualities as responsibility, integrity, organization, dedication, self-starter, highly adaptable and quickly assimilate new concepts
- Strong leadership skills including group working, staff motivation, work with minimum or no supervision, work under pressure and able to carry out multiple tasks
- Great laboratory analysis performance and basic statistical mathematical skills
Certification
ACS certified
References
Reference available upon request.
Languages
Spanish
Native or Bilingual
English
Full Professional
References
References available upon request.
Timeline
Specialist Manufacturing - Process Owner
Amgen Manufacturing Limited
10.2021 - Current
Acting Manager QC NPOC-Water/Wet Chemistry Lab
Amgen Manufacturing Limited
10.2020 - 10.2021
Sr Associate QC NPOC-Water/Wet Chemistry Lab
Amgen Manufacturing Limited
02.2016 - 10.2020
Associate Scientist
Pall Life Science (SLS)
10.2015 - 01.2016
QC Associate- EW NPOC-Water/Wet Chemistry Lab
Amgen Manufacturing Limited
10.2013 - 10.2015
MBA - Medicinal And Pharmaceutical Chemistry
University of Florida
B.S. Chemistry -
University of Puerto Rico, Mayagüez Campus
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