Manager Research Clean Room

EDUCATION

Masters in Pharmacology ****

Purdue University, West Lafayette, IN

B.S Chemistry, Minor in Microbiology 2000

Marquette University, Milwaukee, WI

A.S. Chemical Technology & Quantitative Analysis 2001

MATC Technical College, Milwaukee WI

RESEARCH SKILLS OVERVIEW:

Over fifteen years of laboratory and research experience in pharmaceutical science field

Regulatory experience in Europe, North America, Asia Pac

HPLC, GC, MS, TLC instrumentation, USP dissolution apparatus, Franz diffusion apparatus, method development and troubleshooting

Method development and validation using solid phase extraction, liquid-liquid extraction and protein precipitation from different anticoagulants, matrices and different species

HPLC, UPLC, CE, ELISA, DNA analysis

Conduct internal, site, and vendor GCP/QA audits when directed.

Advanced knowledge of CFRs, GLP, laboratory equipment validation, and laboratory equipment protocol writing.

Knowledge of Food Safety Management System requirements

Strong managerial and analytical ability to solve all analytical troubleshooting.

Attention to detail.

Strong raw ingredient knowledge in pharma and supplements (15+ years)

Powdered beverage and capsule/pill form experience

Strong solid dosage knowledge and experience

Strong process improvement experience

Strong written reporting skills

UVVIS, IR, K-F, pH

Nitric oxide detection

Fourier Transform Infrared Spectroscopy

HPLC (Reverse Phase, Normal Phase, SEC, GPC) (Empower Software)

HPLC Detectors (RI, Fluorescence, CAD, ELSD, PDA, UV)

GC (Direct Inject/Head space)

USP dissolution (Vankel/Distek)

Flow Cytometry

Cell Culture

Lims system software

Analysis Skills

Clinical Study Management or monitoring experience is an asset

GLP or GCLP Experience is a solid asset (21CFR Part 11, 21 CFR Part 58 and OECD Principles)

SKILLS

Very Experienced in purification of biological molecules, including laboratory models for chromatography and filtration systems.

Conducted independent process development

Highly motivated with strong analytical problems solving skills and ability independently on multiple projects concurrently

Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.

Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc, in a multi-disciplinary team environment.

Excellent oral and written communication skills

Experience with downstream purification of biological molecules with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration

Experience in late stage process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.

Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)

Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes.

EXPERIENCE

UPM PHARMACEUTICALS INC BRISTOL, TN

Principle Scientist 2/2018-12/2022

Writing and executing method validation protocols and reports

Performing and writing Laboratory investigations

Flow cytometers example Sony or BD and ability to troubleshoot

Strong instrument and communication experience

15 years of experience in a pharmaceutical industry, working

Oral solid dosage (tablets or capsules) development and testing

Experience in designing, executing experimental related to

Pharmaceutical development as well as interpreting results

Making recommendations

Hands on experience with variety of analytical instruments

Have strong analytical methods development and validation

Also, includes working with regulatory agencies such FDA to ensure compliance

Highly organized and detailed oriented with excellent problem solving and communication skills

CMC experience Europe and Canada

Rediopharmarceuticals

Development of oral solid dosage, tablets or capsules and testing

Responsible for method transfer of various products

Flow cytometers experience and strong communication skills

Familiar with monograph testing such USP, FCC, and BP

Advanced Knowledge with Waters HPLC UV/PDA detector

Frequently used GC packed/capillary FID, UV/Vis, FTIR

Perform dissolution using HPLC, UV/Vis

Develop and validation of analytical methods in compliance with ICH guidelines for novel API and excipient products

Perform content uniformity testing and stability studies

Schedule work for self and others

Identify problems and recommend solutions

Ability to work both independently and collaboratively in a team structure. Holds self and others accountable for achieving collective goals

Interact effectively with UPM cross-functional teams to ensure timely delivery of impurity identification results, phase-appropriate methods and stability study to support in house development of drug substances and products.

Communicate on a timely basis and collaborate closely on analytical method development with UPM preferred contract manufacturing organizations.

Review analytical qualification/validation, in-process and release testing data packages for products manufactured at UPM preferred contract manufacturing organizations.

Perform review and remediation of existing methods.

Performed bioprocessing, assay development and troubleshooting, assay transfer and implement

Provide analytical support for research, development, and manufacturing activities.

Worked with cross-functional partners (Quality, Supply Chain, and Marketing) to develop and manage project timelines to meet business objectives

JF LABS, INC Chicago, IL

Manager food Research & Development 2/2013-2/2018

Responsible for formulating all personal care products to commercialization

managing, developing teams, and executing important projects

Plan, execute, and finalize projects according to strict deadlines and within budget

Acquire resources and coordinate the efforts of team members and third-party contractors or consultants in order to deliver projects according to plan

Define the project's objectives and oversee quality control throughout its life cycle

Ensuring assigned projects are executed in a manner compliant with all regulatory guidelines

Conducting intellectual searches for technical or clinical information through a variety of resources including the Internet

Lead, facilitate and coordinate all project team activities and deliverables as per agreed schedule while managing project expectations with project team members, suppliers and other stakeholders

Lead and perform experimental studies, investigations, and validations

Participate in establishing project strategy and present plans and data to key stakeholders and management

Oversee daily operations of the laboratory Review and approve sample testing study plans for customer projects

Ensure that sample testing projects are performed according to established policies and procedures Maintain budgets for projects to ensure accurate financial accountability

Ensure sufficient personnel, equipment and reagents are available for intended use to execute projects Verify that all Laboratory personnel receive the appropriate training for types and complexity of services offered

Ensure that general laboratory maintenance initiatives are being performed and meet documented requirements

Participate in the human resource management functions Support, mentor and document performance evaluation

Represent the organization in a positive and professional manner in meetings with customers

Excellent organizational, oral, and written communication, and interpersonal skills

Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines

Experience with SAS

Ensure application of Quality by Design (QbD) principals to development and validation activities in accordance with FDA initiatives

Contribute to CMC sections of regulatory filings including IND, NDA, and BLA submissions

FIRST PRIORITY CARE INC Chicago, IL

Lead Formulation Scientist 4/2011-2/2013

Performed R&D investigation of new product, raw material, finished product and stability studies for generic drugs formularies and OTC including personal care products, solid dosage dietary supplement

Provided QC/QA guideline for assay analysis and protocol for the implementation of standard operating procedure and cGMP

Development of oral solid dosage and testing

Provided reports to FDA for new application for drug development

Supported production with new formulation and batch making procedure

Performed assay analysis with HPLC, GC, Karl-Fisher, Titration, Spectrophotometer, Atomic Absorption, FTIR for protein separations

LC/MS methods transfer and validation for new drug discovery application

Developed new analytical methods R&D formulation of topical products

Researched new technologies to improve analytical methods

Troubleshot existing methods

Determined process standards by developing formulas and methods

Prepared analytical method validation protocols, validation reports, test methods, investigation and deviation reports

Develop products to meet customer and business requirements within budgets and timeline constraints. Able to formulate and de-formulate technically challenging products.

ABBOTT LABORATORIES Chicago, IL

Manager QC 5/2006-4/2011

Supervised sixteen degreed chemists in charge of performing investigations of returned Humira auto injector and prefilled syringe complaint samples

Performed preclinical studies on humira prefilled syringe formulations

Mass spectrometry of peptides and proteins, able to obtain and interpret (ESI) LC/MS spectra and conduct MS/MS experiments

Support preclinical API version and form selection.

Uses Lims system to enter data and test results

Develop formulations for use in toxicology studies

Perform preclinical formulation and analytical development

Develop bio enhanced formulations for low solubility compounds

Develop phase appropriate formulations for use in clinical studies.

Perform analytical and stability testing.

Improve existing formulations.

Oversee activities at external contract lab

Experienced in protein chemistry, peptide mapping (enzymatic digests), and working with protein solutions at low concentrations

Prepared reports on customer complaints, and suggested probable causes and recommendations

Up-to-date instrumentation and the following instruments: UV/IR, HPLC, GC and TLC

Computer applications/programs/laboratory applications (i.e., HPLC, FTIR, AA)

Maintain laboroatory equipments are in compliance with requirements and are maintained by the lab staff

Manage all software related documentation system to comply with standards and cGMP’s

Manage sample control through utilization of a system to ensure all samples are logged in and stored in a controlled manner

Manage the laboratory’s staff to use appropriate SOP’s and risk assessment files in the testing/evaluation of samples

Manage the entire laboratory and staff to meet all site Safety standards

Manage the laboratory staff to evaluate Complaint, Manufacturing and autoinjector defect samples. Ensure that the staff creates thorough and comprehensive evaluation reports with concise summaries explaining the lab’s findings

Responsible for the laboratory to create Inspection Qualification kits, Defect Limit samples and Equipment Challenge samples using appropriate materials and documentation practices

Manage the staff to create technical reports

Review and approve laboratory memo’s and technical reports

SC JOHNSON WAX Chicago, IL

R & D Chemist 1/2003-5/2006

Performed formulation of house-hold products, bathroom cleaners, laundry detergents, air fresheners disinfectants, and powder codlings and worked to develop new formula for product applications, participated in the development of new polymers, for consumer products

Provided reports for new product applications based on assay analysis and HPLC and GC

Formulated a patented calcium hypochlorite-based biocide that met customer performance criteria and could be stored as a National Fire Protection Association (NFPA) Class 1 oxidizer

Managed the project from hands-on ideation and experimental design (formulation) through product registration, field trials, pilot and full-scale manufacturing, QA/QC and marketing including video production provided to sales reps

Mass spectrometry of peptides and proteins, able to obtain and interpret (ESI) LC/MS spectra and conduct MS/MS experiments

Experienced in protein chemistry, peptide mapping (enzymatic digests), and working with protein solutions at low concentrations

TRIAD GROUP OF PHAMACEUTICALS Chicago, IL

Laboratory Analytical Chemist 1/2001–1/2003

Prepared test samples

Experience in HPLC & GC analysis

Mass spectrometry of peptides and proteins, able to obtain and interpret (ESI) LC/MS spectra and conduct MS/MS experiments

Experienced in protein chemistry, peptide mapping (enzymatic digests), and working with protein solutions at low concentrations

Identified and communicated OTC monograph requirements relating to new product and labeling development to FDA

Monitored regulatory activities, reviewed USP procedural requirements in the development of master records

Prepared and supported the registration of products internationally

Completed formulation work to ensure flavor & functional ingredient compatibility

Developed plans and conducted sensory optimization with functional ingredients

Worked with R&D Process Development to complete scale-up from bench to pilot plant

Executed initial consumer testing evaluation of scale-up products working with sensory team

Process Development Skills:

Conduct research for new products

Propose changes to improve products and processes

Develop production improvement goals

Inspect product for deviations from customer and product standard(s)

Correct product or process problems

Complexity of mathematics content

Complexity of problem solving

Complexity of scientific inquiry Complexity of understanding the nature of science

Complexity of writing process

Complexity of communication

Business Process Governance and Process Policy Management

Process Performance Management

Business Process Discovery

Organizational Change Techniques

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