Technical Writer Regulatory Affairs

Davison Ejiogu

Ewing, NJ

*********@*******.***; *********@*********.***

*********@*****.***; https://www.linkedin.com/in/davisonsimple/

SUMMARY

Familiar with the following applications: MasterControl, SAP, Domasys, SharePoint, Veeva, Phenix, WebEx, and Microsoft Office.

Regulatory affairs document assessment (IND, ANDAs, Annual Report and Change Control) for FDA Submissions.

Author, Review, Approval of SOPs, and important Dossier for FDA post-approval CMC changes requiring eCTD format for submissions.

Complete CMC sections module 3 of pre-IND and IND packages

Write technical documents, reports, manuals, flow charts.

Drug production experience – Biological and non-biological in different dosage forms.

Prepare regulatory documents on 21 CFR Parts 11, 210 &211,820, and 510k submissions

PROFESSIONAL EXPERIENCE

Adaptimmune Pharmaceuticals Philadelphia, PA April 2022 - Present

CMC Regulatory Technical Writer.

Supports preparation of BLA content including module 3 – Quality

BLA document gap analysis and technical editions

Author Specifications and Acceptance Criteria justifications

Assess and author Control Strategy Reports (CSR)

Draft CMC reports and lifecycle documentation to be used as source materials for BLA content

Ora Clinical Andover, MA February 2021 – March 2022

CMC Regulatory Writer

preparing and reviewing clinical/scientific and regulatory documents.

Prepare IND Briefing Document, IND Responses and CMC Section of Drug Studies (Phases 1,2, and 3) Submissions.

Identify and locate documents on SharePoint site for Content Verification

Identify if document will be referenced in particular section of regulatory filing.

Create master data sheet with all the information.

Takeda Pharmaceuticals International Co. Lexington, MA July 2020 - January 2021

Sr. CMC Documentation Associate

Identify and locate documents on SharePoint site for Content Verification.

Review and author pre/post approval submissions.

Identify and locate documents on SharePoint site for Content Verification

Support Dossier Change Control Management (DCCM) and migration.

Assign appropriate file name and title to reflect the content and create a one-line abstract summary.

SANOFI-AVENTIS Bridgewater Cooperate, NJ January 2018 – October 2018

CMC Regulatory Technical Writer- US Industrial Development.

Chemistry, Manufacturing and Controls (CMC) technical writing for modules 1, 2 and 3 with support to other pharmaceutical departments; manufacturing, marketing, regulatory, QC & QA.

Review Author and Compile Regulatory Dossier for US and International (France, Germany, England, and Japan) to provide technical documentation for global product registrations and pre/post approval submissions.

Work with Product development, process validation and CMC documentation for various dosage forms.

Support Dossier Change Control Management (DCCM) and migration

Write reports or CMC regulatory content or Quality Investigations, Submissions and interact with a multi-disciplined team.

Work with standardized templates and familiarity with US and International regulatory submissions.

Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF Annual updates for assigned products in eCTD format.

Ensure all dossiers follow appropriate SOPs, guidance, GXP and ICH guidance and maintain up to date knowledge. Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions

Work with change control systems and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for submissions.

Work closely with quality, manufacturing, regulatory and technical staff from global locations and with external contractors to communicate, coordinate and track required documentation in support of new and post-approval CMC regulatory activities.

Author and review change control systems, FDA post-approval CMC changes that requires eCTD for submissions.

IMCLONE SYSTEMS Branchburg, NJ June 2017- December 2017

Associate Supply Chain/Technical Writer

Support Migration from local SAP system to global SAP system.

Chemistry, Manufacturing and Controls (CMC) technical writing and communication in pharmaceutical manufacturing, regulatory, quality control and quality assurance.

Support Dossier Change Control Management (DCCM)and migration

Support master data conversion, document revisions.

Work with change control systems, authoring and reviewing FDA post-approval CMC changes requiring eCTD format for submissions

Support the Manufacturing, quality assurance, engineering and variety of other departments by incorporating subject matter expert comments into well-constructed and easy-to-read approvable documents.

Edit/Write a variety of technical articles, reports, manuals, flow charts and other documentation for a wide range of uses, including GMP operations and validation activities.

Assist in assembly of validation package documents for GMP libraries.

QUALITEST-ENDO PHARMACEUTICAL INC. Cranbury, NJ February 2016 – May 2017

Research & Development Scientist

Branded & Generic pharmaceutical product research and development

Evaluate existing processes to identify areas for improvement.

Formulating and establishing product design and performance objectives, normally in consultation with other functions, including research, marketing and production, as well as contractors, suppliers and customers.

Devising new processes, or refining existing ones, to optimize the manufacturing process.

Scaling up the production process via plant trials, making changes to raw materials or components and process parameters to ensure quality is maintained during large-scale production.

Improving yields by reducing costs, through investigating alternative materials or new machinery to improve efficiency, quality and yields in bottleneck areas.

Implementing process controls and devising test methods to assess the production process.

Validating new processes and showing that they are an improvement.

Working with product pipelines at various stages of development.

Reading and writing technical reports and specifications and maintaining appropriate records.

My most recent project was undertaking control of extended-release projects of some of the generic tablets in our research facility.

TRIS PHARMA. Monmouth Junction, NJ May 2013 – January 2016

Technical Services Scientist

Work with the Technical Service Team for Validation Studies, including writing protocols and reports, complying with Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP) and Food and Drug Administration (FDA) requirements

Chemistry, Manufacturing and Controls (CMC) technical writing and communication in pharmaceutical manufacturing, regulatory, quality control and quality assurance

Chemistry Analytical Processing: Use of MC, HPLS, LC

Using Track Wise application for investigations into process deviations, creating investigation reports and implementing the necessary Corrective and Preventative Actions (CAPA)

Work with Submission batches, Technical Transfers, Process Improvement projects, Process Validation, Cleaning Validation, and other projects as necessary

Takes a leadership role on TS projects. Coordinates activities within and across departments. Coordinates project meetings as needed and prepares meeting minutes

Reviews and apply needed changes in the master batch record, Official Forms and Standard Operating Procedures.

Work with Process improvement to implement Change Controls processes and perform tasks associated with the Change Control

Assists Manufacturing and Packaging in troubleshooting, problem solving and product impact analysis

TRIS PHARMA Monmouth Junction, NJ October 2011 – May 2013

Suspension Technician

Suspension and Re-suspension of products components to produce Oral liquid suspension dosage forms in immediate and extended versions

Formulation and development of Oral Solids doses

Granulate, dry, sift, blend and suspend components for final bulk production.

Charge components into vessels, monitor product and room controls until finish

Collect samples for LOD (Moisture testing) and QA testing. Discharge product and store bulks as required

Disconnect all production equipment and major clean equipment and production rooms

Disinfect/sanitize equipment and rooms prior to set-up for next batch processes

ORTHO CLINICAL DIAGNOSTIC INC. (J&J) Raritan, NJ July 1996 – August 2010

Protein formulation Specialist

Perform Human Plasma IgG Antibody Fractionation and purification to produce Rho(D) Immune Globulin (Human) precipitate II. This IgG precipitate II paste is further processed to produce Rh Hemolytic Disease of the Newborn (HDN), The RhoGAM Anti-D Intravenous Vaccine

Actively involved in the RhoGAM Vaccine improvement project, the Viral Inactivation Project, to establish additional viral removal process step using Solvent/ Detergent technology

Perform stability tests on intermediate & finished Batches

Small molecule processing, In-process media preparation & Ligand Binding Assay

Work with minimum supervision and directly involved with the write/revision of MBRs, SOPs, specifications, and other relevant GMP documents.

Use of Accuri's C6 Flow Cytometer System for counting and examining microscopic particles, such as cells and chromosomes, by suspending them in a stream of fluid and passing them by an electronic detection apparatus

EDUCATION

B.S. Science & Applied Management: Grand Canyon University March/2022

A.S. Biotechnology: Raritan Valley Community College May/2011

A.S. Science/Mathematics: Raritan Valley Community College May/2011

A.S. Pre-Medical Professional: Raritan Valley Community College May/2011

B.Sc. Biology/Chemistry Buffalo State College (Sr. Unfinished)

CERTIFICATES:

CA. (PMP) Mastery Project Management. Rutgers State University New Brunswick, NJ 02/16-07/16

CA. (PMP) Project Professional 2010 Rutgers State University New Brunswick, NJ 02/16-07/16

ACHIEVEMENTS:

Bronze Award- In Recognition of his Special Achievement and Participation During Production Process International Audit. Demonstrated Professional Production Process Knowledge that led to new international customer acceptance.

Silver Award-Recognition of Special Achievement-Exceed goal in 1st Pass Acceptance for RhoGAM Production

Gold Award-Recognition of Special Achievement: Demonstrated commitment to the RhoGAM Vaccine production.

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