Justin Shawn Sanchez, PMP

Gainesville, Georgia **504 • 404-***-**** • ad36wo@r.postjobfree.com

Professional Summary

Focused Project Manager adept at planning, directing, and maintaining continuous operations in various departments. Experienced in directing cross-functional and keeping efficient production by quality standards. Applying creative and analytical approaches to operations for continuous process improvement. Skilled at identifying or anticipating problems and providing solutions. Excels through mentoring, training, and empowering the team to excel in performance. Skills

Root Cause Analysis

Project Planning

Compliance Monitoring

Project Management

Project Tracking

Document Management

Advanced Problem Solving

Stakeholder Communications

Agile and Waterfall Methodology

Analytical Skills

Change Management

Risk Assessment

Work History

Project Manager, Product Development, 10/2020 to 09/2023 Kiel Laboratories, Inc. – Flowery Branch, GA

Planned, designed, and scheduled phases for multiple large projects each with budgets ranging between 5-10 million dollars.

Directly to the CEO and CFO with a targeted focus on project management with multiple clients, marketing partners, and sponsors

Track the scope of projects in MS Excel and MS Projects Manage projects from development through the 505(b)(2) regulatory pathway to the commercial phase utilizing Waterfall, Agile and Hybrid project management methodologies Create and maintain budgets for projects

Create meeting agendas and meeting minutes to communicate the project status, current action items, potential risks, and scope changes to stakeholders Work in parallel with the Medical Director to see that all regulatory filings for Clinical Trials are filed in a timely manner to meet milestones for the customer/stakeholder timelines Implement and communicate any scope changes, risks, and impacts to the projects Oversee regulatory filings with FDA, Health Canada, and other regulatory agencies Responsible for RFPs to CMOs and evaluating quotations to determine the most appropriate CMO for product transfers

Manage the technical transfer of products to CMOs. Project Manager, Research and Development, 07/2017 to 10/2020 Kiel Laboratories, Inc. – Flowery Branch, GA

Reported directly to the VP of R&D while focusing primarily on 505(b)(2) drug product development from the R&D phase to commercial launch Created weekly lab schedules and monitored/tracked lab activities Executed and updated: laboratory SOPs, analytical test methods, and R&D manufacturing batch records

Implemented HPLCs utilizing Empower software, dissolution systems, UV-Vis, and viscometers for increased laboratory capabilities

Performed troubleshooting and maintenance on all lab equipment Managed analytical method development and non-GMP method validation per ICH Q2 (R2) guidelines

Directed formulation development including pH studies, solubility studies, excipient compatibility, in vitro dissolution profile analysis for in vivo solubility extrapolation, and stability studies Responsible for the procurement of raw materials, raw material technical information, and API / excipients as required

Assured that all product formulation excipients met the IIG database guidelines Determined Quality Target Product Profile (QTPP) for finished product (FP), Critical Quality Attributes (CQA) for FP, and FP specifications

Performed FP shelf-life projections utilizing statistical software Familiar with patent searching on FDA Orange Book to evaluate potential patent infringements with New Drug Product Formulation

Led the design/evaluation of drug product formulations and their manufacturing processes for liquid dosage forms

Led problem-solving and troubleshooting activities related to drug product development and optimizing manufacturing process parameters

Responsible for the preparation of analytical method development protocols/reports, non-GMP method validation protocols/reports, technical transfer reports, product development reports, and other CMC documents

Oversaw external CMO manufacturing of pilot/demonstration batches, and submission/registration batches.

Senior Chemist, Shift Lead, 03/2016 to 07/2017

KIK Custom Products – Gainesville, GA

Finished product testing; raw materials testing; analytical methods validation; stability testing and trend analysis; creating stability data reports and certificates of analysis; maintained accurate documentation of all analytical methods performed per GLP guidelines; lab batch preparation and batch adjustment calculation; batch pH adjustments ordering laboratory supplies as needed; performing routine calibration and maintenance of laboratory instruments per SOPs Directed shift analysts' duties.

QC Analyst II, 06/2014 to 01/2016

Mikart – Atlanta, GA

Finished product testing; raw materials testing; analytical methods validation; performing stability testing and trend analysis; maintaining accurate documentation of all analytical methods performed per GLP guidelines; and performing routine calibration and maintenance of laboratory instruments per test procedures and SOPs.

Scientist I, 12/2011 to 06/2014

Encompass Pharmaceutical Services, Inc. – Norcross, GA Finished product testing; raw materials testing; analytical methods validation; method development; performing stability testing and trend analysis; creating stability data reports and certificates of analysis; maintaining accurate documentation of all analytical methods performed per GLP guidelines; maintaining inventory of chemicals/reagents; ordering laboratory supplies as needed; performing routine calibration and maintenance of laboratory instruments per SOPs. Education

Undergraduate: Bioscience Technology

Gwinnett Technical College - Lawrenceville, GA

Undergraduate: Biochemistry

Georgia State University - Atlanta, GA

Certifications

PMP - Project Management Professional, Credential # 3655827

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