**** ********* **

Randallstown, MD *****

443-***-****

ad3bvp@r.postjobfree.com

John J. Sakal II

Qualification Summary

Hands on professional with over 15 years of combined experience in the following areas:

QC and QA Pharmaceutical/biopharmaceuticals

Integrating and implementing cGLP/cGMP, ISO 9001 practices and guidance.

Wright and review QC laboratory testing standards and standard operating procedures (SOP’s).

Supervising analysts for Environmental Monitored the cGMP cleanroom areas, Raw Materials lab.

Training new chemists and lab technicians in the use of laboratory equipment, instrumentation.

Conduct training in quality assurances practices, policies, QC methodology and safety precautions.

Develop plans and implement validation, method development, tech transfers as well as plans to continuous operations in

emergency situations.

Work on emergency building of a Smallpox viral filling facility after 9/11.

Major input in writing, executing and supervising the validation plan for the Water For Injection system (WFI) in the

Smallpox viral filling facility.

Build out new laboratory and production areas.

Set up lab equipment and validate them.

Helped execute Covid-19 response under operation warp speed for two different companies.

Interface with a number of government agencies working on various projects and contracts, including the military.

Interface with clients and project managers to alleviate problems with raw materials and tech transfers.

Help company set up there covid-19 policies.

Key Strengths

Drafting and reviewing technical reports.

Management of hazardous materials per EPA and local regulations.

Review laboratory notebooks per quality assurances practices and policies.

Subject matter expert of various chemical analyses using specialized equipment and instrumentation

pH/Temp/mV meter, Ocean Optics USB 2000 Spectrum, CHEM2-VIS-FIBER, Amperometry titrator, Sievers 800

Series TOC Analyzer, FTIR, UV-VIS, Autoclave, Karl Fischer (KF), Dissolution Bath, HPLC (Waters, Empower III

Software).

Sterilization, clean room gown certified.

Minitab, and Radiation Safety Training, Lyophilization Testing (USP).

Expertise with FDA, USP, FCC, EU, BP, JP regulations and quality guidance.

LIMS.

Sample raw materials using aseptic techniques in a class D clean room.

Work with FDA and DEA class narcotics (class 1).

Professional Experience

Analytical Chemist Pharmaceutics International INC.(Pii), 10950 Beaver Dam Rd, Hunt Valley, MD 21031 09/26/2022-

11/03/2022 Check the quality of raw materials via company’s SOP's, USP, EP, JP and in-process testing (specific gravity) of

narcotics drug product per SOP’s, USP, EP, JP, while observing FDA and DEA drug procedures for handling narcotics.

Lab Technician (Chemist), Mistral Inc., 10001 Franklin Square Drive, Suite A, Nottingham, MD 21236 11/29/2021-11/03/2022.

Working all aspects of the company's need for a chemist in the manufacture and R & D of test kits (colorimetric) for explosive

and narcotics at all levels, batch making, filling liquid products, QC, QA, writing SDS, data review at all levels (batch records),

hazardous waste disposal, helping with the COVID-19 response within the company. Upgrade the production lab to do more

manufacturing at the Nottingham site with safety in mind.

QA Raw Material Supervisor, Contractor, The Fountain Group, 4505 Woodland Corporate Blvd., Suite 200,

Tampa, FL 33614 (Catalent Pharma Solutions, Jessup, MD (CAV 2)) 4/5/2021-5/17/2021.

Assigned to the contract Manufacturing (CMO) warehouse conducts critical reviews of cGMP documentation associated with the

disposition of raw materials to be used for such projects as COVID 19 vaccines, COVID 19 therapeutics and other client projects. Maintain and update

various QA trackers and spreadsheets. Worked with Materials Control to quarantine and disposition raw materials in a timely

manner. Dispositioning quarantined raw materials in a warehouse environment. Worked cross-functionally with Materials

Control, Purchasing, Manufacturing, Quality Control and other departments to resolve raw material quality issues and

provide assistance when needed. Flexibility in dispositioning materials that may include off-hour or weekend work. Offers

suggestions for correcting problems and for improving processes. Review all data that was generated at the warehouse location.

QC Raw Material, Contractor, Alku, Inc. 200 Brickstone SQ, Suite 503, Andover, MA 01810

(Emergent Biosolutions Inc., Bayview, Baltimore, MD) 8/31/2020 – 01/29/2021.

Consultant on Operation Warp Speed for the COVID-19 Vaccine in the Quality Control Department raw materials.

Inspected components, Chemicals, Testing of raw materials, Help Set up the central warehouse, help management at all levels to

ensure that the SOPs and cGMP were followed and improved through the high paced environment of Operation Warp Speed.

Train and mentor new analysts. Review and authorize data in LIMS (Sample Manager 10 sp2 from Thermo Scientific) for Water

for Injection (WFI), Environmental Monitoring (EM) and Raw materials test.

Contractor FAS Services, Sykesville, MD., 5/2017- Present.

Leaning erosion control, environmental paperwork, excavation equipment and other scientific work as needed.

QC, Chemist 1., Cadista Pharmaceuticals Inc., 207 Kiley Dr., Salisbury, MD 21801, 8/11/13-11/20/15.

Analyzed raw materials and final product per USP prior to release. Review laboratory notebooks per quality assurances practices

and policies. Disposition of raw materials, components and drug products. Support the management of the CAPA process.

Assist in Quality metric reports. Assist in investigations, deviations and CAPAs. Utilized UV-Vis Spectrophotometer, FT-IR,

Metrohm DL-38 KFD Titrino, HPLC Agilent Technologies 1260 Infinity, HPLC Waters 2695 Separations Module, UPLC Waters

Acquity, HPLC Software Empower.

Lab Tech III, Optimus Management Group, Hartford, CT (work site Hunt Valley, MD), 4/30/2012-7/24/12

Formula test batches for cosmetic per SOP’S. Fill test bottle and formulas analytical per SOP’S. Date enter. Disposition of

raw materials and components.

Enrichment Teacher, Beth El Pre-School, 8101 Park Heights Ave Baltimore, Md. 21208, 1/12/-2/12.

To give 4 & 5-year-old am introduction to basic science. Develop lesson plan. Order supplies. Disposition of waste safely.

Product Development Scientist, Taylor Technologies, Inc. Sparks, MD, 11/2004 - 11/2011.

Integrate and implement ISO 9001 practices and policies. Develop water test kits for swimming pools, Cooling Tower, Boilers,

Industrial Discharge. Assisted in the development of the Taylor Colorimeter. Assist in the re-formulation of all Phenol Red regents

for swimming pools test kits. Standardize NSF pool water for test kits and the manufacture of Cl2 demand-free water for Cl2

standards (Free Cl2, Total Cl2, chloramines.). . Evaluate new dropper tips and set standards for QC. Adjust the FAS-DPD reagent to

use a different multiplier. Set up stability protocols. Disposition of raw materials and components. Utilize Beckman Φ 250

pH/Temp/ mV meter, Bausch & Lomb Spectronic 501 UV-Vis, Shimadzu UV-1700 Pharma Spec UV-Vis Spectrophotometer, US

filter series A-790 amperometry titrator daily.

Supervisor, Environmental Monitoring/Raw Materials Lab, Chesapeake Biological Laboratories, Inc. Baltimore, MD,

9/2000 - 5/2003.

Supervised analysts who monitored the cGMP areas for particulate and bacterial levels. Supervised and trained analysts in Raw

Materials testing as per USP, EP, JP, BP and FCC. Responsible for signing off data associated with Environmental

Monitoring/Raw Materials Lab. Supervised and participated in the testing and validation of water for injection (WFI) lines for BL

2/3 manufacturing facilities. (For the Smallpox vaccination project after 9/11). Disposition of raw materials, components and drug

products. Authored and executed protocols for the validation master plan of the WFI and clean steam systems.

Raw Materials Chemist, Method Development Chemist, Chesapeake Biological Laboratories, Inc. Baltimore, MD,

9/2000 - 5/2003.

Analyzed raw materials per USP, EP, JP, BP and FCC prior to release of these materials to production. Monitored the water for

injection (WFI) system per USP, EP, JP, BP and FCC. Trained new chemists in the use of testing procedures per USP, EP, JP, BP,

FCC and on quality assurances practices and policies. Responsible for raw material inventories and sampling in the receiving

warehouse and quarantined areas. Authored and executed protocols for the validation master plan of the WFI and clean steam

systems. Developed analytical methods for in-process, finished product and stability samples. Developed and revised laboratory

SOPs and test methods and other drafts of quality documents. Disposition of raw materials, components and drug products.

Support the management of the ARP process. Authored and executed change controls protocols. Utilized Spectra Max 340,

Beckman Du 600 UV-Vis Spectrophotometer, Perkin Elmer 1600 FT-IR, Metrohm DL-38 KFD Titrino, and TOC daily.

Research Assistant - Research Foundation State University of NY at Stony Brook Stony Brook, NY, 1/1999 - 5/2000.

Assisted with the research of uranium-to-uranium oxide breakdown under varying conditions with citric acid. Performed FT-IR

and X-ray Photoelectron Spectroscopy (XPS) in support of the research. Assisted other technicians with setup and performing

uranium analyses using FT-IR. Utilized vacuum ultraviolet (VUV) ring for the analysis of uranium-to-uranium oxide at National

Synchrotron Light Source at Brookhaven National Labs.

Research Assistant - Department of Material Sciences, State University of NY at Stony Brook Stony Brook, NY,

1/1999 - 5/2000.

Assisted with the research of uranium-to-uranium oxide breakdown under varying conditions with citric acid. Performed FT-IR

and X-ray Photoelectron Spectroscopy (XPS) in support of the research. Assisted PhDs and MS candidates with setup and

performing analyses using FT-IR, X-ray Photoelectron Spectroscopy (XPS), Utilized vacuum ultraviolet (uVu) ring at National

Synchrotron Light Source at Brookhaven National Labs.

Laboratory Technician, Permagile Industries, Inc. Plainview, NY, 7/1994 - 5/1995

Responsible for quality control of epoxy adhesive and urethane during manufacture. Generated and maintained analytical data

for in-process and final product testing. Maintained laboratory Material Safety Data Sheets. Responsible for the disposal of

hazardous and non-hazardous materials.

Education

CRA Academy (Clinical Research Associated Academy)

cGMP, GLP, GCP, Protecting Human Research Participants, Shipping of Category A, Infectious Substance Affecting

Humans, Category B, Biological Substance, Transporting Dangerous Goods training.

State University of NY at Stony Brook Stony Brook, NY

B.S., Chemistry

Courses of Particular Interest: Environmental Law and Regulations, Survey of Toxicology, and Materials

Handling and Hazardous Waste Disposal.

State University of NY Morrisville, NY

College of Agriculture and Technology

A.S., Chemistry

Specialized Skills and Professional Development

cGMP Training: Training modules designed to ensure understanding of compliance to applicable federal

regulations.

Asceptic Technique and Process Control Corporate Training Program: Became familiar with aseptic techniques

and flow of operations to ensure high quality product development and release under sterile conditions.

Hazardous Materials Safety Training:

General Safety: Familiar with OSHA Standards and laboratory safety.

Computer Skills: Proficient with Microsoft Word, Excel, and Access as well as Internet, on-line ordering, email, Min-Tab.

Transporting Dangerous Goods Certificate: Training modules designed to ensure understanding of compliance to applicable

federal regulations.

Transporting Category A and B Certificate: Shipping of Category A, Infectious Substance Affecting

Humans, Category B, Biological Substance,

Protecting Human Research Participants Certificate: Training modules designed to ensure understanding of compliance to

the safety and right of human research subjects.

cGCP Certificate: Training modules designed to ensure understanding of compliance to applicable federal

regulations for clinical trials.

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