Technology Specialist Packaging

ALADE KAYODE (KAY) DOSUMU

Naugatuck, CT *****

Cell Phone: 203-***-****

Email: *******@*****.***

SUMMARY

Motivated professional with managerial experience in technical support (scale-up, technology transfer, alternate APIs/Excipients supplier qualification and trouble-shooting) for variety of pharmaceutical dosage forms (solid/liquid – tablets, capsules, solutions, suspensions, biologics and transdermal) as well as validation activities (master planning, process validation, cleaning verification/validation, bulk hold time studies, annual product review, shipping studies, packaging validation, project management and quality system).

Strengths include pragmatic application of problem-solving skills and managing resources for scale-up, technology transfer, new product introduction and validation activities. Consummate team player who fosters and encourages strong working relationships with various functional groups to work cooperatively and collaboratively to achieve the company’s goals in a timely fashion.

PROFESSIONAL EXPERIENCE

LANNETT COMPANY, INC 2018 – 2022

Carmel, NY

Senior Auditor, R&D Quality Assurance

Supported the quality and compliance of documentations generated by and activities of Research and Development – Product Development (PD), Analytical R&D (ARD) and Technical Services (TS).

Reviewed and/or approved Good Manufacturing Practice (cGMP) documentation – Standard Operating Procedures (SOPs), corporate policies, qualification/validation plans, User Requirements Specifications (URS), Functional and Design (FS & DS), Testing protocols (IQ/OQ/PQ), User Acceptance testing, deviations, validation reports, and change controls to support all AR&D Laboratory instruments and development pilot plant qualification.

Supported Site Technical Services group on timely review and approval of proposed submission (ANDA) Manufacturing, Filling and Packaging batch records, deviations/investigations, corrective and preventive actions (CAPAs), Validation Protocols and Reports. Reviewed, approved and release executed Manufacturing, Filling and Packaging batch records and Clinical studies protocols and reports for ANDA submissions.

In collaboration with R&D and RA, ensure the quality of R&D generated documentation (Product Development Reports) are submission-ready and right-the-first-time (RTFT).

In collaboration with Supplier Quality Management, reviewed and/or approved of documentations (deviations, investigations, CAPAs, change controls, validation protocols/reports etc.) generated by External Manufacturers/Third Party follow cGMP and in compliance with the company quality program.

IMPAX LABORATORIES, INC (formerly CorePharma, LLC.) 2010 – 2017

Middlesex, NJ

Manager, Pharmaceutical Technology (2013 – 2017)

Supported External Manufacturing Technical Service for Tech Transfer of New Products through Contract Manufacturing Organizations (CMOs) and Contract Packaging Organizations (CPOs) – assessing gaps in the manufacturing, packaging, method transfer, data integrity, deviations/investigations, corrective and prevention actions (CAPAs), change controls, equipment/facility/critical utility from originating sites to receiving sites.

Subject Matter Expert (SME) for Tech Transfer of Commercial and New Products from Middlesex, NJ site to Hayward, CA and Taiwan sites.

Reviewed and approved protocols and reports for Equipment qualification, Method Transfer, Process Verification/Validation/Optimization, Cleaning, Packaging and Computer Systems Validation and related SOPs, deviations/investigations, corrective and preventive actions (CAPAs).

Involved in New Product Launch project meetings and activities - verification/validation manufacturing batch records/protocols, change request orders (CR/Os) initiation, floor-work with the manufacturing Technicians, data analyses, final reports and regulatory submissions.

Authored and coached direct reporting staff on good documentation practices and data integrity aligned with the CFR, company policies and quality system.

Served as Pharm Tech technical guidance for manufacturing, deviations/CAPA, packaging, regulatory affairs, quality assurance and quality control with expert knowledge of product formulation and development of robust processes.

Exploited latest manufacturing technologies and implement product and process optimization techniques leading to manufacturing cost efficiency while maximizing quality.

Participated in and approved the interviewing, hiring and training of departmental employees and conduct mid-year and annual performance evaluations for direct reporting staff.

Served as an Interim Director (February 2015 – July 2015), managed a staff of 12 Pharmaceutical Specialists/Engineers/Consultants to conduct Process Validation, Cleaning Verification/Validation, Computer Systems Validation, New Product Introduction, Equipment Qualification, Alternate API/Excipient Supplier Qualification and Packaging Validation.

Principal, Pharmaceutical Technology Specialist (February 2010 – October 2013)

Lead project for the re-introduction of six encapsulated products – revised the Master Manufacturing Batch Records, updated the Standard Operating Procedures and re-trained Manufacturing Technicians on encapsulation.

Participated in successful remediation program for FDA Warning Letters/Critical 483’s that brought the site into compliance. The program led to removal of the Warning Letter and approval of new commercial products.

Performed scale-up and process validation for high volume Immediate and Extended-Release commercial products.

Coordinated all activities for Continuous Process Monitoring and data management (Statistical Process Control) of commercial products.

Authored the conversion of the original Portrait Manufacturing/Packaging Batch Records into Landscape sub-sectioned modular format as per cGMP and for process improvement.

Involved in Process Validation/Optimization/Manufacturing support of Corepharma/Amendra CMO products.

Provided technical/diligent study including data integrity/audit for potential new NDA/ANDA products in collaboration with Project Management, Regulatory Compliance and Regulatory Affairs.

ALLERGAN (formerly ACTAVIS, WATSON LABORATORIES, INC.) 1997 – 2009

Pharmaceutical Technology Dept., Danbury, CT & Carmel, NY

Pharmaceutical Technology Specialist III (2007 – 2009)

Pharmaceutical Technology Specialist II (2003 – 2006)

Senior Scientist (2001 – 2002)

Scientist (1997 – 2000)

Managed complex projects such as introduction of new products - Abbreviated New Drug Applications (ANDAs)/New Drug Applications (NDA), batch Scale-Up/Scale-Down, Process Optimization/Validation, Technology Transfer, Qualification of new Active Pharmaceutical Ingredients (APIs)/Excipients Suppliers, Cleaning Validation, Equipment Qualification and Packaging Validation.

Collaborated with R&D, Manufacturing, Engineering, Quality Operations and Regulatory Affairs – successfully manufactured and filed six new Immediate Release ANDA and four Extended Release ANDA batches at the Carmel site. Approved products led to new product introductions and launches for the company.

As a core member on 16 new ANDA projects, prepared exhibit batch records/protocols, executed the floor-work with manufacturing Technicians and prepared final reports.

Provided Regulatory Affairs with proposed commercial batch records, technical and data generated from manufacturing equipment for Quality by Design (QbD) product submissions for Abbreviated New Drug Applications (ANDAs)/New Drug Applications (NDA).

Served as a SME for process validation (New Product Launch) during an FDA site inspection/PAI.

Implemented many process optimization/validation and technology transfer projects that saved several million dollars in manufacturing costs. These projects included:

Scaled batch sizes up to reduce number of batches produced in manufacturing as well as reducing laboratory costs.

Performed experimental work to optimize the manufacturing process of 4 products by changing from Glen Mixer (Low Shear) granulation and oven drying (tray drying) to Collette Gral Mixer (High Shear) granulation and Fluid Bed Drying processes. 3 products with these changes were filed and approved - significantly reducing the manufacturing time and operational cost for these products.

Implemented multi-tip tooling in tableting to increase machine output.

Involved in the transfer of products to and from the Carmel/Danbury sites. Transferred of products to Carmel (NY) from Stockholm (Sweden), Miami, (FL) and Puerto Rico sites when those facilities were closed. Also involved in the transfer of products from Carmel to Watson facilities in Davis (Florida), Corona (California) and Goa/Mumbai, India when the site was closed in 2009.

Optimized and validated compression and encapsulation speeds of 11 products, resulting in double machine speeds and significant reduction in production cost.

Recommended corrective actions to upgrade process technologies and improve regulatory compliance in Manufacturing and Packaging operations.

Collaborated with Manufacturing & Quality Operations to solve process related problems/ deviations (NCIs and NCRs). Provided technical support and issued Corrective Actions & Preventive Actions (CAPA) to each problem.

Participated in pre-development, development and technology transfer activities from R&D to Company sites with Pharmaceutical Technology, Manufacturing and Quality Assurance departments.

Revised and updated all documentation associated with 15 commercial products including master manufacturing batch records, packaging batch records, and standard operating procedures.

Supervised and conducted post-validation training to the Manufacturing Technicians on validated manufacturing processes and products.

Performed Installation, Operational and Performance Qualifications on new production equipment and re-qualification of existing equipment.

Experienced with several types of manufacturing equipment for low/high shear granulation, compression, encapsulation, aqueous and solvent film coating as well as tablet printing.

Collaborated with team members to plan and execute qualification of product packaging lines.

WATSON LABORATORIES, INC (formerly Schein Pharmaceutical, Inc.)

Laboratory Operations, Carmel, NY

Senior Chemist/Group Leader (1994 – 1997)

Chemist (1991 – 1994)

Responsible for ensuring the quality of Schein products were in compliance with FDA and USP compendial regulations.

Performed analytical testing and release of raw materials and finished products, stability and product complaint samples.

Scheduled workload for Chemists and Analysts in the group.

Initiated/updated Quality Control Standard Operating Procedures (SOPs), Out of Specification (OOS)/Out of Trend (OOT) investigations and Deviations.

Served as lab data reviewer for finished products release.

Performed calibration, maintenance and troubleshooting of laboratory instruments.

Trained new Analysts and Chemists on instrumentation, troubleshooting and documentation.

Instruments used: GC, HPLC, FITR, AA, NMR, UV-vis and Fluorescence Spectroscopy.

HERBERT V. SHUSTER, INC., Quincy, MA 1989 – 1991

Chemist

Performed analytical testing on various pharmaceutical, nutritional, foods and cosmetic products using wet chemistry techniques and instrumentation - GC, HPLC, FITR, AA, and UV-VIS Spectroscopy.

Developed improve analytical procedures and techniques for household products under the supervision of Technical Services Manager.

EDUCATION AND PROFESSIONAL MEMBERSHIP

Six Sigma Green Belt Certificate

Union County College (Continue Education), Elizabeth Campus, NJ

M. S. Pharmaceutics/Industrial Pharmacy

Arnold & Marie Schwartz College of Pharmacy and Health Sciences,

Long Island University (Westchester & Brooklyn Campuses)

M. Sc. Food Technology (Quality Control)

University of Reading, Reading, England,

B. Sc. Chemistry and Food Technology

University of Alexandria, Alexandria, Egypt,

American Chemical Society

American Society of Quality

SHORT COURSES AND SEMINARS

Current Practices in Fluid Bed Drying, Granulating and Particle Coating Technology

Advanced Film-Coating Technology

How to Supervise People

Advanced HPLC for the Practicing Chromatographers

Statistics in Validation

Design of Experiments

Process Analytical Technology

Project Team Building

Flow of Solids in Pharmaceutical Operations

The Fundamentals of Project Management

Pharmaceutical Process Development

TECHNICAL SKILLS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Minitab

Visual Basic

Microsoft Access

R&R Report Writer

SAP

LIMS

MasterControl

TrackWise®

Microsoft Visio

Statgraphics

JMP

SKILLS

Project Management

Technical Problem Solving

Superior Time Management

Product Management

New Product Introduction

Working with multifunctional teams

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