Justin Shawn Sanchez
Gainesville,Georgia
Summary
Focused Project Manager adept at planning, directing and maintaining continuous operations in various departments. Experienced in directing manufacturing employees and keeping efficient production in accordance with quality standards. Applying creative and analytical approach to operations for continuous process improvement. Skilled at identifying or anticipating problems and providing solutions. Excels through mentoring, training and empowering team to excel in performance.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Project Manager
Kiel Laboratories, Inc.
10.2020 - 09.2023
- Report 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 MP 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.
Manager of Analytical and Formulation Development
Kiel Laboratories, Inc.
07.2017 - 10.2020
- 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
KIK Custom Products
03.2016 - 07.2017
- 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
Mikart
06.2014 - 01.2016
- 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
Encompass Pharmaceutical Services, Inc.
12.2011 - 06.2014
- 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, GAUndergraduate - Biochemistry
Georgia State University
Atlanta, GASkills
- Root Cause Analysis
- Project Planning
- Compliance Monitoring
- Project Management
- Project Tracking
- Document Management
- Advanced Problem Solving
- Stakeholder Communications
- Agile Methodology
- Analytical Skills
- Change Management
- Risk Assessment
Certification
- PMP - Project Management Professional, Credential # 3655827
Timeline
Project Manager
Kiel Laboratories, Inc.
10.2020 - 09.2023
Manager of Analytical and Formulation Development
Kiel Laboratories, Inc.
07.2017 - 10.2020
Senior Chemist, Shift Lead
KIK Custom Products
03.2016 - 07.2017
QC Analyst II
Mikart
06.2014 - 01.2016
Scientist I
Encompass Pharmaceutical Services, Inc.
12.2011 - 06.2014
Undergraduate - Bioscience Technology
Gwinnett Technical College
Undergraduate - Biochemistry
Georgia State University
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