AMOS ATONGA

6 Ridge Road, Edison, NJ 08817 * (732) 287-6001 / (732) 586-2849 * amosatonga@ho

tmail.com
CHEMIST / ANALYTICAL QC SPECIALIST
A proven leader in helping organizations achieve a higher level of maturity and
success through oversight, development, and evolution of their scientific workfo
rce, R&D programs, and laboratory process and infrastructure.
CORE COMPETENCIES
* PHARMACEUTICAL / BIOPHARMACEUTICAL * REGULATORY COMPLIANCE * PROJECT MANAGEMEN
T
* PROCESS ANALYSIS / QUALITY CONTROL * EMPLOYEE / LAB SUPERVISION * LAB EQUIPMEN
T MAINTENANCE
* EXCEPTIONAL COMMUNICATOR * WET CHEMISTRY * DISSOLUTION TESTING
* TECHNIQUES: GC, GC/MS, HPLC & LC/MS * SAMPLE PREP: SPE, SPME, LLE , SFE & ASE
* FTIR, NIR, UV/VIS, & AA
PROFESSIONAL EXPERIENCE
MERCK & CO., INC. - (1994-2010)
MANUFACTURING SR. FACILITATOR / SUPERVISOR - Viral Vaccine Manufacturing - West
Point, PA 2008-2010
Major Functions: Directed daily bulk vaccine manufacturing operations. Supervise
d employees engaged in vaccine production in a clean, scientific work environmen
t which included scheduling and allocating work based on production priorities,
critical work checks and performance evaluations, continuous training, providing
technical guidance, and resolving any problems that arose. Ensured every emplo
yee met dress and safety codes, were competent and qualified for the duties assi
gned, and maintained lab/production areas and equipment at inspection ready stat
us at all times. Tracked projects, wrote reports, maintained records, updated S
OPs, Process Specific Training Manuals, and Control Procedures, demonstrated kno
wledge of cGMP, and administered local agreements, company personnel policies, a
nd OSHA and company safety procedures.
* Promoted a positive, team oriented work environment where open communication w
as encouraged which led to smooth, seamless operations, consistently high produc
tion rates, and completing work on time and in budget.
LABORATORY QUALITY SUPERVISOR - Rahway, NJ 2002-2008
Major Functions: Spearheaded daily operations management for the Quality Contro
l Lab; established project priorities and managed testing and disposition of pha
rmaceutical components in an expedient, compliant manner. Participated in inter
nal and FDA inspections of the laboratory-passed all audits.
* Supervised a group of analysts working in-process monitoring samples, manufact
ured isolated intermediates, finished projects and technical operations regulato
ry support projects.
SR. SCIENTIST - Quality Control - Rahway, NJ 1998-2002
Major Functions: Worked closely with the Research/Development laboratories and Q
uality Unit groups to ensure that methods development/optimization, validation a
nd verification, and ensuing technology transfer were executed in a timely manne
r. Modified and validated chromatographic methods for assay of pharmaceutical co
mponents, drug product containers, and closures. Evaluated and acquired new anal
ytical technologies such as laboratory instruments, computer hardware and softwa
re for the department. Performed the calibration and validation of laboratory in
struments. Supported and performed launching of new products. Coordinated and pe
rformed technical training of analytical chemists on analytical instrument techn
iques such as HPLC, LC/MS, GC, GC/MS, spectroscopy, wet chemistry and physical t
esting. Ensured that associate analysts were appropriately trained on cGMPs, SOP
s and safety policies. Coordinated the review of any changes or updates of compe
ndia procedures by Quality Control laboratories, Quality Assurance and other app
ropriate quality department. Ensured that laboratory testing was performed in a
ccordance with current USP/NF, BP, EP, JP and /or other applicable procedures. P
erformed and coordinated analytical method transfer, data review, creation and r
evision of SOPs as well as routine release, stability testing and related repor
ts. Oversaw and performed analytical work in support of manufacturing equipment
cleaning validation. Provided analytical support for investigations and product
complaints testing. Evaluated OOS investigations and ensured that appropriate c
orrective actions were followed as stipulated in the FDA and cGMP guidelines and
company policy. Participated in internal and FDA laboratory inspections.
QUALITY CONTROL CHEMIST - Rahway, NJ 1994-1998
Major Functions: Supported and perfumed analysis in process monitoring samples,
manufactured isolated intermediates, finished products and Technical Operations
regulatory projects. Performed sample preparation, assay and identification of r
aw materials, recipients, intermediates and finished products by UV-Vis, HPLC, L
C/MS, TLC, GC, GC/MS, IR, Tachymetry and Karl Fischer Titrator. Participated in
pharmaceutical in-process testing including blend homogeneity, dissolution, disi
ntegration, content uniformity, particle size and friability tests. Assisted in
general maintenance and calibration of lab equipments. Monitored the cleanliness
of production machinery and surrounding areas with GMP compliance.
PFIZER INC. - Parsippany, NJ
QUALITY CONTROL SUPERVISOR - Consumer Health Care Group 1993-1994
Major Functions: Supervised analysts working on different projects namely: stabi
lity studies, analysis of raw materials, finished/complaint products. Modified a
nd validated HPLC, GC, spectroscopic and wet chemical methods in support of the
developments of new personal care product formulations. Performed qualitative, q
uantitative and investigational chemical analyses of raw materials, pilot scale
production samples, finished packages, complaint samples, and packaging componen
ts. Carried out troubleshooting of routine testing methodologies and prepared te
chnical transfer protocols and reports. Reviewed and verified analytical test re
sults generated by other chemists. Calibrated laboratory equipment as required.
Performed and documented laboratory investigations. Designed, authored the codin
g scheme for 5 years of safety studies on personal and healthcare products by ca
taloging results of pre-clinical and clinical studies reducing the organization
budget for this work by 30%. Maintained products safety assurance databases and
assisted the implementation of on-line document retrieval system.
STAFF CHEMIST - Analytical Laboratory for R&D - Rahway, NJ 1990-1993
Major Functions: Performed chemical analysis of drug formulations using both wet
and instrumental techniques namely: HPLC,GC,UV.TLC,VK6010DIS,Titrtor,Viscometer
,KF,PH Meter, DIS.Tester, AA and FT-IR. Analyzed pharmaceutical products, raw ma
terials, active ingredients and stability samples. Conducted stability studies o
n drug products at different set points. Modified and validated HPLC, LC/MS, GC,
GC/MS, spectroscopic and wet chemical methods in support of the developments of
drug formulations. Performed qualitative, quantitative and investigational chem
ical analyses of raw materials, different drug formulations, finished products,
complaint samples, and packaging components. Carried out troubleshooting of rout
ine testing methodologies and prepared technical transfer protocols and reports.
Reviewed and verified analytical test results generated by other chemists. Cali
brated laboratory equipment as required. Performed and documented laboratory inv
estigations. Maintained products safety assurance databases and assisted the imp
lementation of on-line document retrieval system.
SQUIBB INSTITUTE FOR MEDICAL RESEARCH - Lawrenceville, NJ
CHEMIST - Analytical Laboratory for R&D 1989-1990
Major Functions: Performed wet chemical analysis of drug candidates using differ
ent modern analytical techniques namely: Titration methods, TGA, IC, HPLC, FT-IR
, and IR, MS, KF, UV, GC, CHN Analyzer, AA and other separation techniques. Posi
tion required interaction with other departments, working independently on resea
rch projects, and experience with computers, good written / verbal communication
skills and familiarity with USP/NF.
EDUCATION & TRAINING
GRADUATE COURSE - CHEMISTRY RUTGERS UNIVERSITY - New Brunswick, NJ (Currently At
tending)
GRADUATE COURSE - CHEMISTRY UNIVERSITY OF NAIROBI - Nairobi, Kenya
B.S. DEGREE - CHEMISTRY RAMAPO COLLEGE OF NEW JERSEY - Mahwah, NJ
Specialized Training
* Leadership Effectiveness
* Critical Problem Solving
* Effective Communication
* How to Manage Multiple Projects, Meet Deadlines & Achieve Objectives
* Practical HPLC Troubleshooting
* Negotiating Skills
* 21 CFR Part 11: Scope and Applications
* Performance Management
* Good Laboratory Practice
* Current Good Manufacturing Practice
* Radioactive Safety
* Fundamental and Advanced Dissolution Testing
* Systems and Process Validation Fundamentals
* Humans Resources: Policies and Procedures
* Advanced HPLC Methods Development