Andrew Apeanyo
Rockville,Maryland
Summary
A Regulatory and Clinical Pharmaceutical Industry Professional with extensive experience of document publishing, submission compilation, life cycle management and dispatching global regulatory submissions compliant with Health Authority electronic requirements. Looking for opportunities in the Pharmaceuticals, Bio-pharmaceuticals and Medical Devices industry.
Overview
4
4
years of professional experience
Work History
Associate Scientist/Associate Technical Writer
AstraZeneca Pharmaceuticals
06.2022 - Current
- Develop and characterize purification processes and assays for the manufacture of complex biopharmaceuticals including monoclonal antibodies, vaccines, anti-drug Antibodies, and viral vectors
- · Perform and conduct investigations; write problem reports, CAPAs, deviations, and change controls on internal nonconformances and customer complaints related to Reagents using JMP and DLIMS software
- Assist Senior Scientist in small molecule drug development within discovery organization and performed intricate research within strict timeline and communicated results to Directors & stakeholders.
- Gathers, coordinated and submitted to the FDA all appropriate documents, correspondence and final reports for the US IND and post marketing annual reports.
- Perform Data verifications on research drugs prior to submissions to FDA
- · Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as In-Line projects such as site transfers.
Technical Deviation Writer
Catalent Pharmaceuticals
09.2022 - 07.2023
- Create and revise standard operating procedures for production, and master batch records under Vvault and Trackwise for MFG department.
- Assist engineering to develop manufacturing equipment improvements, quality improvements, and line performance improvements.
- · Responsibilities include the development and coordination of the pre-commercial pharmaceutics activities associated with the drug development process, including CMC data registration for investigational products and materials management activities in support of clinical trial support.
- Proved successful working within tight deadlines and a fast-paced environment and edited and proofread technical documents for accuracy and consistency.
- Worked closely with software engineers, product managers and other departments to determine accuracy and completeness of technical documentation.
- Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as In-Line projects such as site transfers.
- Revise and request master batch records including interacting with other departments and clients as necessary; assemble batch related documentation and complete reviews prior to transfer to Quality Assurance; develops proper documentation for batch production.
Senior Scientist/Technical Writer III
AbbVie
06.2021 - 03.2022
- Developed and/or reviewed regulatory documents to ensure that all submissions are complete, accurate, and meet relevant requirements according to ICH and FDA guidelines.
- Reviewed and evaluated scientific data, analytical methods and reports required for drug product development and submission in regulatory applications.
- Worked with document owners to ensure internal templates and guidelines are used for document creation.-Ensure or perform quality control checking of documents. Includes QC of data, tables, formatting, and style.
- Ensured a streamlined process for publishing and document control by developing and maintaining publishing procedures and authoring SOPs where needed.
- Work with Drug Discovery ELN software to develop chemical drug product for pre-clinical trials and Author/review/approve CMC-related IND amendments, NDA supplements and CMC sections of annual reports.
- Replicated drug products for senior directors for clinical trials
Senior Scientist
Kashiv BioSciences
06.2020 - 07.2021
- Documented changes during experiments, noting unexpected issues arising during research activities.
- Conducted experiments in laboratory environment for product development purposes.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Prioritized project tasks after discussions with Quality, MFG, and Microbiology department team.
- · Oversees the development and optimization of manufacturing processes upstream and downstream for new and existing drug products.
- Work with ELN and Master Control software to develop chemical drug product for manufacturing drug lot.
- Serve as functional CMC representative on assigned New Product Development teams and related technical task forces as well as In-Line projects such as site transfers.
- Perform routine and non-routine quality assurance audits to include clinical investigator sites, and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.
Quality Assurance Chemist
CSL Behring
01.2020 - 05.2020
- Advised chemists and laboratory technicians on existing and emerging quality control methods to enhance testing and research capabilities.
- Collaborated with laboratory technicians, production personnel and customers to improve product quality and functionality.
- Calibrated HPLC equipment and documented readings and adjustments to improve equipment accuracy.
- Developed new analytical techniques and enhanced existing analytical methods to improve testing validity and applicability.
- · Tested raw materials, and/or finished product to quality controls to ensure compliance with quality standards and applicable government regulations.
- Developed manuscripts and edit SOPs, SMPs, Batch Records for quality control analyst using Master control Software.
- ·Performed tasks associated with HPLC, UPLC, and GC testing for GMP release of raw materials and drug product.
Education
Master of Science - Drug Discovery & Development
Drexel University
Philadelphia, PA12.2024
Bachelor of Science - Biological Sciences
Northern Illinois University & Drexel University
Dekalb, IL12.2019
Bachelor of Science - Neuroscience
University of Scranton
Scranton, PA2015
Skills
- Scientific Methodologies
- Assay Development
- Research and Experiments
- Research Design
- Experimental Design
- Quick Learner
- Cross-Functional Teamwork
- Information Verification
- Data Verification
- Impact Assessment
- Technical Guidance
- Regulatory Submissions
- Audits
- Validation Protocols
- Clinical Trials Protocols
Timeline
Technical Deviation Writer
Catalent Pharmaceuticals
09.2022 - 07.2023
Associate Scientist/Associate Technical Writer
AstraZeneca Pharmaceuticals
06.2022 - Current
Senior Scientist/Technical Writer III
AbbVie
06.2021 - 03.2022
Senior Scientist
Kashiv BioSciences
06.2020 - 07.2021
Quality Assurance Chemist
CSL Behring
01.2020 - 05.2020
Master of Science - Drug Discovery & Development
Drexel University
Bachelor of Science - Biological Sciences
Northern Illinois University & Drexel University
Bachelor of Science - Neuroscience
University of Scranton