Print date: **-May-*****-May-**
Monsurat Ajagbe
**** ****** **. ********* ** 53562
Preferred Tel: 773-***-****
*********@****.************* Vitae
ofof
Monsurat O. Ajagbe
SYNOPSIS
Over threeeightnine years of pharmaceutical/ biotechnology analysis experience including
analytical method development, validation, and optimization experience of small and large
molecules.
Proficient in cGMP regulations, ICH and FDA guidelines interpretations and analytical data
review.
Review of analytical data, reports, protocols, methods and SOP’s for Quality and Regulatory
compliance.
Review of investigations, non-conformances and CAPAs
ASQ Certified Quality Auditor. Also about five years experience in Quality Control Laboratory in
Beverage industry.
EMPLOYMENT
JAN, 2014: PPD Middleton, WI Associate Group Leader
• Organize, schedule and make recommendations for production activities and needs, also
oversee daily operations to ensure quality and project timeliness, and assist in
preparation and implementation of company training programs.
• Ensure that projects are completed in a timely manner so that company revenues are
met and clients continue to be satisfied with the quality and timeliness of work
performed, the quality of work performed continues to meet or exceed company
requirements and production staff and needs continue to be developed to keep pace
with department goals and growth.
• Prioritize and track various method verification, validation, or optimization projects,
and notify client and leadership team of accomplishments and/or issues.
• Provide assistance inConduct analytical data review, validation protocol and method
review, and report generation. Also enhance leadership skills and act as role model for
department staff.
• Supervise and enhance performance and career development for a team of 3-5 analysts.
• Set annual departmental goals that align with the company's strategic objectives,
communicate these goals to staff, track performance, and mitigate performance gaps
against these goals.
• Identify and lead strategic or continuous improvement projects that enhance the
laboratory's quality, technical, or business systems.
MAY, 2010: PPD Middleton, WI Senior Quality Assurance Auditor
• Ensured the quality of laboratory procedures, data, and reports by evaluating for
compliance with analytical methods, protocols (validation and stability), standard
operating procedures, client criteria, and applicable FDA regulations.
• Reviewed analytical data, reports, protocols, and methods, auditing equipment
qualification, computer validation, general laboratory records, laboratory analysts
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training records, conducting in-process inspection, general facility, vendor, and
subcontractor laboratory inspections.
• Provided interpretation and consultation to project teams on regulations, guidelines,
compliance status, and policies and procedures
• Evaluated policies and procedures for compliance with applicable regulations/guidelines and
provide recommendations to management for continuous process improvements.
• Assist in training of new Quality Assurance staff
• Collaborated with departmental and cross-functional teams to address cGMP
compliance issues and complete projects as assigned. Develop and maintain effective
relationships with internal and external stakeholders which include regional and global
entities.
• Demonstrated prudent independent judgment to balance quality expectations and
other stakeholder needs.
• Participated in working teams to provide direction regarding quality and compliance
and QA department requirements as needed
• Reviewed investigations, non- conformances (Quality Events and Deviations) and CAPAs
via QAAD/ PARTNER from initiation to close out.
• Planned and conducted facility audits and in-process and laboratory inspections for
compliance with organization’s policies and applicable laws
JUN, 2005: Since
2005
MM/YY to Current: PPD Development, Middleton, WI (Job Title) : Responsible for
Senior Scientist Research and Development
• Project leader on multiple projects, including interaction with clients, review and
evaluation of data, writing reports and protocols, in compliance with cGMPs and
GLPs
• Independently performed complex chromatographic method development and
validation, by means of HPLC and GC.
• Prepared protocols, development and validation reports for clients. Managed assigned
projects and schedule available resources to meet deadlines. Participate in client
communications regarding establishment of project requirements and status of
projects.
• Mentored and trained associate and assistant scientists.
• Performed various types of protein characterization assays including, SDS-PAGE, 2-
dimensional electrophoresis,Western Blots, ELISA, Bradford assay, Kinetic assays,
Osmolality, Peptide Mapping, IEF, SEC.
April, 2003: Responsibilities include performing a variety of complex sample
preparation analysis procedures to quantitatively measure pharmaceutical
compounds in a variety of formulation.
Evaluate method development/validation techniques being utilized and
offer suggestions to improve efficiency.
Independent performance of complex laboratory analysis of pharmaceutical
compounds on a wide range of analytical instruments (HPLC, GC, UV, IR,
particle size (Malvern).
Since04/2003 -
12/2004
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MM/YY to MM/YY: Neo Pharm Inc. Waukegan, IL
Research Associate
• Supported in the development of critical parameters for liposomal formulations/ products.
Provided analytical support using HPLC (DAD & ELSD) and wet chemistry, for In-process,
Entrapment Efficiency, Clinical trial and cGMP samples (Lyophilized and liquid
formulations).
• PerformedPlanned and methodconducted method development, validation and transfer. .
• Wrote Prepared and distributed tTechnical reports and protocols.
Reviewed stability data.
April, 2002: 04/2002 -
04/2003 American Pharmaceutical PartnersAPP Melrose Park, IL
Quality Control Chemist
• Applied analytical technique/instrumentation to assure batch uniformity and integrity of
incoming raw materials, in process and stability products.
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• JAN, 2001:
Applied analytical techniques/instrumentation to assure batch uniformity and integrity of
incoming raw materials/in process/stability/finished products by performing analytical testing
of products using HPLC from Waters and Agilent with Millennium, Empower and
Chemstation Software, GC, AA, TLC, FTIR, UV-VIS, Autotitrators, Particle Sizer,
Osmolarity Instrument and general wet chemistry methods.
Managed laboratory operations and audited out of specification investigations.
Managed quality control laboratory operations with knowledge of cGMP, GLP regulatory
guidance on technology transfer from product development to manufacturing. Reviewed,
verified and approved test data to ensure product release in quality assurance.
01/2001-
03/2002 Phoenix Laboratory Hicksville, NY Hicksville, NY
Analytical Chemist
• Performed Raw Material and Product Analysis, determination of active ingredients in
various compounds and formulae using HPLC, AA, GC and UV spectrometer. Identification
of compounds, using the IR and monitoring of the biodisintegrationbio disintegration of
tablets and wet chemistry, Stability testing.
• Trained new laboratory personnel in methodology, laboratory techniques and use of
instrumentation.
• Conducted release rate testing, managed and assisted in administration of laboratory
operations.
• Coordinated with production and quality assurance department
• Conducted safety inspections, audits and inventory.
Supervised lab-technicians ensured that results not meeting specifications are promptly
investigated and applicable actions implemented.
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JUN, 19992002: One year as QC Safety Officer updated MSDS, conducted Fire
Drills and monthly safety meetings.
06/1999-
08/1999 USEPA Chicago, Illinois
Research Intern for Lake Michigan Group
• Compiled the Fish Consumption Advisories and the Chemical Toxins found in Lake
Michigan and its tributaries which will eventually be used in the production of the lake wide
Management Plan.
JUN, 1993: 06/1993-
03/1998 Consolidated Breweries Plc. Ijebu-ode Nigeria
Quality Control Analyst
• Conducted Raw material analysis and finished product analysis of alcoholic and non-
alcoholic products, e.g., determination of water hardness and softness, chloride test,
determination of bitterness, color Oxygen and CO2 content of product using UV
spectrophotometer, haze meter, oxy-tester, CO2and CO2 tester.
• Trained new laboratory personnel in methodology, laboratory techniques and use of
instrumentation.
Coordinated with production and quality assurance department.
Previous Relevant Employment
AREAS OF EXPERTISE
HPLC Analyses- Evaluation of potency of drug product; assay and impurity
methods.
EDUCATION
Roosevelt University Chicago, IL May 2005
•
MSc. Biotechnology and Chemical Sciences
•
University of Illinois Chicago June 1999
• Health Careers Organization, School of Public Health Summer Residential Program
University of Ibadan Nigeria
• BSc. (honors), Biochemistry October 1992
PROFESSIONAL DEVELOPMENT
Certificate of Qualification: Instrument Installation, Operation and Maintenance of Polymer
•
Laboratories Evaporative Light Scattering Detector
• High Performance Liquid Chromatography by LC Resources
• Certificate of Completion: GLP Training Course
• Member American Society for Quality – ASQ Certified Quality Auditor (12/01/2012-
12/31/2016 cert # 44220
• EDGE Certification –Nov. 2012
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Skills
Knowledge of word-processing, spreadsheet, and database applications.
Extensive knowledge of pharmaceutical research and development processes and
•
regulatory environments.
Knowledge of quality assurance processes and procedures.
•
Strong interpersonal skills.
•
Excellent problem solving, conflict resolution, risk analysis and negotiation skills.
•
Strong training capabilities.
•
Effective organization, communication, and team orientation skills
•
Ability to manage one or more areas of responsibility. Demonstrate experience in
•
executing quality strategy with minimal management oversight.
Effective written and oral communication, interpersonal skills, facilitation and
•
influencing skills with an ability to effectively work across the group and external
stakeholders.
In depth knowledge of cGMP and other regulations as required with a broad
•
knowledge of quality principles and industry trends.
Knowledge ofProficient in MS Office, PowerPoint, word-processing, spreadsheet, and
•
database applications.
PROFESSIONAL AFFILIATIONS
PUBLICATIONS
• Co-authored, “A Rapid Isocratic Method for Determination of Cholesterol and 1, 2-
Dioleoyl-sn-Glycero-3-Phosphocholine (DOPC) in Liposome-based Drug Formulations”.
Journal of Chromatography A.
References:
Katherine Keiser, PhD: Quality Assurance Supervisor
Biopharmaceutical Testing
PPD Inc., 8551 Research Way Middleton WI
Tel: 608-***-**** FAX: 608-***-****
Dan D. Hobson, Associate Group Leader
Biopharmaceutical Testing
PPD Inc., 8551 Research Way Middleton WI
Tel: 608-***-**** FAX: 608-***-****
Terri Strother, Senior Research Scientist
Biopharmaceutical Testing
PPD Inc., 8551 Research Way Middleton WI
Tel: 608-***-**** FAX: 608-***-****
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PRESENTATIONS
Employee Signature Date_ Date
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