JACQUELINE KIM CORREA

305-***-**** adytes@r.postjobfree.com

SUMMARY

Preformulation chemist, biochemist, and director for performing analytical characterization, quality investigations, DNA forensics, and protein engineering, leading to approval of 3 major applications by the FDA and intellectual property, proficient with significant number of methods used in pharmaceutical, cosmetics, food, and dietary supplement development.

LABORATORY SKILLS

Six Sigma Certified

cGMP, GLP, GDP, GCP

FDA submission and registration

Project management and statistical analysis

NDA, IND, IMPD

Global Pharmaceutical, Nutraceutical, Food and Cosmetics

API characterization and preformulation

OOS, RCA, Change Control, NCR, CAPA

TACT, Excel, LIMS, Veeva PowerPoint, Citrix, Oracle, Empower, Wisdom, Visio, QC10, AS400, Mastercontrol

UPLC, HPLC, GC-MS, UV-IR, DSC, PSD, DVS, TAM III, SEM

Method technical transfer

DOE, Method validation

Lean Manufacturing

SOP, STP, and Protocols

NPD/R&D/QC/QA/RA

OSHA, EPA, DOH, EU, Health Canada, UK

ISO (9001, 22000, 22716)

EXPERIENCE

Nestle Health Science US, December 2020 – present

Quality Director

Responsible for leading the NHS quality control and quality assurance operations which includes auditing, annual budgeting, domestic and international lean manufacturing for internal and contract manufacturer organizations (CMOs).

Developed strategic quality and process improvement initiatives that established a culture of quality.

Overseen the quality process from Research & Development Design through commercialization.

Led the development and maintenance of quality systems programs, policies, processes, procedures, and controls ensuring that performance and quality of the Quality Management System complies with regulation, standards, and agency guidelines.

Designed control oversight including review and approval of design development documentation for all phases of development from feasibility, planning, design, Verification, Validation and Design Transfer stages including risk management files and change controls.

Strong knowledge of quality methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control.

Designed control oversight including review and approval of design development documentation for all phases of development from feasibility, planning design, Verification and Design Transfer, technology transfer, equivalence studies, bulk hold studies, including risk management and change control.

Implemented statistical process control methods to monitor and analyze manufacturing processes and drive continuous improvement efforts.

Responsible for ensuring compliance with team studies, FDA and health authority submissions, third-party certification management, international registration, data management, Release to Commerce, Operations, Safety, Pharmacovigilance and Regulatory Affairs.

Responsible for keeping current with global health authority laws and regulations, identifying gaps and implementing process improvements resulting from new or revised regulations or guidance.

Strong Clinical quality expertise across Nestle Health Science global, clinical trial regulations (e.g., ICH, FDA, ISO, ect.), and guidelines in GCLP, CAP, CLIA, GCP and GMP.

Responsible for the approval and compliance of internal and external audit reports, quality events, deviations, product claims, drug facts, specifications, stability program management, expiration dating, laboratory OOS investigations, root cause analysis, corrective actions, preventative actions, risk and impact assessments within the Veeva Vault quality management system.

Established and maintained a global inspection readiness program, external health authority inspections, internal audits and mock-recall audit readiness program.

Collaborated with suppliers and external partners to ensure the quality of incoming materials and components.

Responsible for supplier qualification and quality oversight of material suppliers (e.g., media, chemicals, excipients, single use systems, primary and secondary packaging components and device) under a SQM function.

Expert knowledge of incoming inspection processes including material inspection plans certifications of materials and AQLs.

Knowledge of filling packaging operations and related issues: Single use systems (extractables and leachable leakage defects); Syringes (glass breakage cl/ certification); Needles (defect investigations); Stoppers (knowledge of coring, particulate investigations); Devices (auto injector issues, needle guard issues, component manufacturing); Vials (delamination issues, cracked vials, manufacturing process).

Monitored and measured the effectiveness of suppliers, vendor qualification approvals, third-party raw material vendor approval, annual vendor review, material board review and provided periodic updates to shareholders.

Led the Nestle Sustainability Project, a company-wide initiative focused on integrating sustainable practices into all aspects of the business (e.g., assessed the environmental impact of operations and identified opportunities for improvement in areas such as waste reduction, energy efficiency, and water conservation).

Aligned and negotiated Quality Agreement terms with internal stakeholders and external partners.

Collaborated with the Chief Financial Officer and finance team to establish robust financial controls, budgeting processes, and expense management systems.

Conducted regular financial reviews and analyses to identify areas for cost optimization, revenue enhancement, and resource allocation.

Led cross-functional teams to develop and implement process improvement initiatives, resulting in increased productivity, cost savings, and streamlined operations.

Monitored key performance indicators (KPIs) to evaluate operational and financial performance, effectiveness of suppliers, vendor qualification approvals, third-party raw material vendor approval, annual vendor review, material board review and provided periodic updates to shareholders.

Implemented workload management strategies to ensure equitable distribution of responsibilities and prevent excessive workloads among team members.

Established performance evaluation frameworks and metrics to assess individual and team performance, identifying areas for development and recognition.

Fostered a culture of accountability, transparency, and collaboration, promoting effective communication and cross-functional collaboration.

Hired, trained, supervised, mentored, and developed team members, including Directors of Finance and Operations, Quality Assurance, Quality Control, Regulatory Affairs, Privacy & Data Protection Counsel (in conjunction with the General Counsel), People Operations/Human Resources, Operations Coordinator, and other team members as appropriate.

Image Skincare Manufacturing LLC., October 2018 – December 2020

Quality Manager

Managed a team of 40 quality chemist, microbiologists, engineers, technicians and coordinators located at the corporate and international manufacturing sites

Improved and standardized new drug application processes for Over-the Counter drugs and ensured alignment with co-manufacturers.

Managed ten domestic and international contract manufacturer and raw material suppliers.

Established quality standards and policies for dietary supplement, food supplement, cosmetics, and Over-the-Counter drugs.

Collaborated with the Director of Finance and Operations to coordinate and execute the annual budget planning process for the quality department.

Monitored the progress of the department’s objectives and financial priorities throughout the year, making adjustments as needed.

Ensured that the quality department operates within the allocated budget, implementing cost-effective measures without compromising quality standards.

Worked closely with the finance team to track and analyze the department’s financial performance, providing insights and recommendations for financial improvement.

Participate in cross-functional meetings to prioritize and allocate resources based on financial considerations and business needs.

Established internal, external, and responsible supplier audits to drive continuous quality improvement.

Responsible for FDA audit preparations and FDA NDA/ANDA inspection audits internal and external vendor audits.

Accessed and evaluated supplier manufacturing capabilities, quality control, and quality assurance to drive supplier quality improvement.

Developed and maintained product specification standards across all raw materials and finished good products manufactured on site and at affiliated contract manufacturers and suppliers.

Created and managed corporate quality management systems and aligned standardized expectations with suppliers (SOPs for quality, testing methods, quality agreements, product specifications and protocols)

Provided vendors regular feedback on product performance to address negative product trends or issues, quality score cards and annual vendor reviews.

Ensured manufacturing processes comply with standards at both domestic and international level.

Identified and created process to standardized and product testing across all products reducing laboratory testing that operate in compliance with cGMP.

Subject matter expert for quality regulations, Prop 65, USP, FSMA, FDA, Health Canada, EU Commission, BRAC, GMP, GDP, GLD, CMC, ICP, ISO 9000, LACF, 21 CRF part 111, 112, 113.

Created a standardized process for the collection, retention and uploading of all quality documents and third-party audit data.

Served as a leader in cross functional meetings to prioritize and move forward business decisions

Represent the QA function during cross functional meetings and provide key data for presentation

Monitored stability trends and performance and set product specifications for all finished good products

Prepare and update quality documentation, based on ISO 9000 – Quality Management, published by the International Organization for Standardization

Reviewed statistical data from the production lines to identify quality problems and establish corrective action

Established regular data reporting and work with team to establish report structures

Analyzed data and recommend changes to production processes or quality controls to eliminate the problem

Analyzed records of product returns to identify specific problems or trends over time

Developed and monitor continuous improvement programs, aiming to reduce the number of defects and improve levels of quality

Ensured financial goal and deadlines are met By facilitating And assessing processes, situations while taking corrective actions as required.

The Nature’s Bounty Company, QC Laboratory May 2017 October 2018

Quality Control Supervisor

Managed a team of 30 chemists, microbiologists, technicians and coordinators in a HPO environment.

Overseen daily operations of the QC laboratory including incoming raw materials, testing, screening, in-process product testing, release of finished dietary supplements, utilities and environmental monitoring.

Maintained a safe, monitored, functional and operational compliance environment in accordance with the organization’s policies, procedures, and state, federal and local laws.

Responsible for implementing and overseeing the comprehensive safety program including safety audits, supplies and training to reduce accident rates and comply with OSHA standards.

Responsible for the Regulatory and Safety of all chemicals, raw materials and formulas.

Collaborated with the finance department to develop the annual budget for the quality control laboratory.

Manage the department’s expenses and resources in alignment with the allocated budget.

Work closely with the Director of Finance to track and analyze the financial performance of the quality control department.

Identified opportunities for cost optimization and resource allocation to maximize efficiency and maintain financial targets.

Provided financial data and insights to support decision-making processes within the quality control laboratory.

Collaborated with cross-functional teams, including finance and operations, to ensure financial objectives are met and resources are effectively utilized.

Ensured company-wide compliance, registration, and reporting for all applicable regulatory agencies USP, URL, EU, DEC, DOT, REACH, FDA and Department of Health.

Responsible for FDA, USP, and URL audits and preparations.

Streamlined Company project proposals, preliminary plans to determine time frame, funding and budgeting limitations, procedures for accomplishing project, staffing requirements, Corrective Action Preventive Action (CAPA), and allotment of available resources to various phases of the project.

Coordinated activities with Planning, Manufacturing, and Quality Assurance to ensure production schedules are met.

Overseen investigations related to the laboratory including Out of Specification laboratory results (OOS), root cause analysis, nonconformity investigations, and CAPA for prevention.

Responsible for packaging update and assessment, data management and registration guideline.

Responsible for reviewing and developing change control, deviations, and non-conformities reports.

Accountable for designing weekly and monthly project plans, timelines, scheduling project meetings, setting agendas, calculating laboratory metrics (KPI), preparing and presenting project progress.

Collaborated with vendors on supply, product specification, product testing and regulation through the application of quality tools and techniques.

Ensured company-wide cGMP compliance (21 CFR part 111), performance maintenance, repair and calibration of laboratory instrumentation/equipment, and evaluation of new equipment methodology.

Overseen product development, validation and implementation of new assays, and transfers of assays from R&D.

Investigated and escalated consumer issues and complaints related to product quality.

Responsible for associate development, teambuilding, training, and review of performance evaluation.

Teva Pharmaceuticals, Respiratory Research and Development March 2013 March 2017

R&D Laboratory Manager

Managed a team of 4 preformulation chemists in a R&D environment.

Executed Teva Branded Pharmaceutical Products Research and Development laboratory techniques to simulate and identify factors that influence aerosol transport by generating experimental data to validate pulmonary drug delivery to the lungs from dry powder inhalers (DPI).

Responsible for the drug approval of two NDAs and one major NDA supplement (AirDuo 208799 Jan 2017, ArmonAir 208798 Jan 2017, QVAR SUPPL 27 May 2014) which are inhalation dosage forms, managed schedule of testing and report writing to deliver content for FDA submissions.

Responsible for Pediatric drug development and pediatric drug approval for NDA supplement (AirDuo 208799 Jan 2017, and QVAR SUPPL 27 May 2014).

Overseen daily operations of the preformulation laboratory including incoming raw materials, testing, screening, in-process product testing, device and finished product testing.

Ensure department compliance, registration, and reporting for all applicable regulatory agencies: FDA, OSHA, EPA, DOT, FAA, DEC, EU, REACH and Department of Health

Designed and modified SOPs, STPs, protocols, IND/IMPD summary documents, PK report, method technical transfers, validations, and experimental plans (QbD, DoE) for the formulation development on oral controlled release and immediate release dosage forms to analyze parameters of raw materials.

Monitored the creation and maintenance of written specifications for all raw materials, packaging, and finished goods to ensure quality, identity, potency, uniformity, purity, and any other relevant factors pertaining to an item's suitability for use.

Corresponded with API & excipient suppliers, packaging suppliers, and contract manufacturers to ensure compliance with regulations and the drug product specifications.

Characterized API (amorphous content, micronized and unmicronized materials), excipients, other preformulation materials, in-process materials, released materials, and finished materials under cGMP conditions by creating project planning and timelines, executing data evaluation and approval, conducting investigations, and authoring reports formatted to FDA submission standards.

Directed training courses on cGMPs (21 CFR 211), GDPs, SOPs, STPs, IND, IMPD, CTX, USP and ICH guidelines for pharmaceutical product development and testing.

Responsible for FDA audit preparations and FDA NDA/ANDA inspection audits.

Responsible for the qualification and maintenance R&D instruments/equipment and IQ/OQ/PQ activities of new equipment for the formulations department.

Expert with the following solid state characterization techniques (independently lead): UPLC, GCMS, LCMS, UVIR, PSD by Malvern and Sympatec, surface area and pore size by BET, dissolution, heat of solution by TAM III, water content by Karl Fischer, surface structure by SEM, XRPD, glass transition by DSC, phase transition by DVS, drug dose content uniformity (DDU), drug content (assay), net content (fill) weight, BU sampling, tapped density, and total energy by Powder Rheometer.

Baptist Hospital, Laboratory Services June 2009 – March 2013

Laboratory Manager

Managed a team of 20 chemists and microbiologists in a clinical laboratory environment.

Overseen laboratory operations for treatment and diagnosis of diseases (serology, bacteriology, biochemistry, hematology, microbiology) and biotherapeutic research projects.

Directed and lead all CLA and GLP-related activities of the Company to ensure compliance.

Overseen quality system including third-party service providers' compliance with local and state regulations.

In conjunction with validation group, developed and managed all validation policies, procedures, and protocols.

Responsible for hiring and leading qualified staff, ensuring maintenance of equipment and facilities, and maintaining the quality system to produce reliable results.

Managed the Corrective Action Preventive Action (CAPA) process, documentation control, deviations process, internally and with contract organizations.

Managed to continuously improve and streamline the change control system and worked directly with functional areas to review and approve change controls.

Provided the direction and oversight necessary to ensure the completeness, timeliness, consistency, accuracy, and security (including storage) of Quality data including entries, calculations, reports, and any other type of data used as pertinent to the operation of the Company.

Expert with the following testing methods: UPLC/HPLC, GC-MS, Western blot, ELISA, GC-MS, SEM, CE, and SDS-PAGE.

Barry University, Department of Science Laboratory January 2008 June 2009

Laboratory Supervisor

Managed 10 research chemists in an analytical and biochemical research environment.

Conducted research on liquid-fill and semi-solid formulations (single excipient and multi-component mix), low dose content uniformity, highly potent containment, low melting point, delayed release, absorption, viscosity, temperature, stability, fill weight, physical characteristics, filling and sealing technologies (banding and microspray) for soft and hard gelatin capsules.

Performed immunoassays, cell-based assays, molecular biology assays and virology testing for the development and validation of oligonucleotides, and bioassays (ELISA and surface plasmon resonance (SPR), whole cell immunoassay by flow cytometry, gene expression analysis and gene therapy with oligonucleotides).

Directed mammalian cell culture methods (inhibition, induction, etc.), manipulation of micro-organisms and/or viral infectivity.

Lead experiments on DNA isolation, fingerprinting by PCR, DNA, protein synthesis, lipid-based systems, enzyme kinetics, analysis of polymers and analysis of unknown molecules.

Proficient with the following testing methods: Liquid encapsulation microspray sealing (LEMS), ELISA type assays (colorimetric, fluorimetric, chemiluminescent, etc.) and/or qPCR molecular assays, UPLC/HPLC, CE, SDS-PAGE, Western blot, carbohydrate analysis, GC-MS, XRPD, UV/IR, GC-MS, NMR spectrometer, Refractometer, pH testing, titration and SEM.

EDUCATION

Master of Science: Pharmaceutical Science and Chemistry focused on drug discovery and targeting

Nova Southeastern University, June 2016

Bachelor of Science: Math and Chemistry, with Biochemical engineering specialization focused on compound optimization and manipulation

Barry University, June 2009

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