CARLOS S.

BUFORD
39 Sycamore Drive
East Stroudsburg, Pa
(570) 629-4618
cbc331c6@westpost.net
Project/Manufacturing Management
Pharmaceutical professional with extensive parenteral and solid dosage form deve
lopment and project/manufacturing management experience. Successfully created,
managed and directed the development of a multi-million dollar parenteral/Cytoto
xic GMP suite and coordinated multiple project development teams. Spearheaded mu
ltiple department collaborations to ensure critical clinical timelines were met
and managed the support for multiple biological process departments including di
rect supervision over vaccine production and packaging. I have extensive blister
line and bottle line packaging experience leading and operating blister line pa
ckaging and bottle line PET (Performance Enhancement Team) changeover team.
PROFESSIONAL EXPERIENCE
SANOFI-AVENTIS Malvern, Pa
Sr. Research Investigator 2006-2010
To implement, complete and manage the development and start-up of the Parenteral
/Cytotoxic suite within the Pharmaceutical Sciences Department. Manage the proje
ct and coordinate all qualifications, equipment installations and vendor require
ments in compliance with all FDA, EMEA, and cGMP requirements. Liaise with vario
us departments to develop their products and manage technical transfer protocols
from formulators to manufacturing.
* Successfully created, managed and led the multi-million Parenteral/Cytotoxic G
MP suite implementation and validation in a class C environment. Developed and
directed the intra-department support for training, audits by outside agencies,
(U.S. and Europe) and facilities upgrades with the facilities engineering group,
Health and Environmental Services.
* Championed Industrial Affairs in their life cycle development of commercialize
d products which included modified and immediate release specifications for deve
lopment in the Japanese market. There were many regulatory challenges such as ta
blet design and appearance that our team successfully accomplished.
* Currently directing the initiative with the Clinical Packaging Operation Group
(CPO), to resolve issues (locally and globally sourced products) with PSD compo
unds being shipped to be package by their department. This has streamlined the p
rocess allowing their department to meet critical clinical timelines.
* Streamlined R&D development scale-up, from tech batches to clinical batches, s
cheduling processing activities. R&D projects, development and clinical work by
planning activities using Microsoft Project. This included personnel, equipment
and formulators.
* Developed and authored the Cleaning Verification and Microbial Impact Protocol
for the US region to meet global GMP requirements. Led the collaboration in coo
rdinating the execution between sites to ensure continuity. Currently directing
managing the sampling and data collection for the project.
DISCOVERY LABS INC. Totowa, NJ
Manager- Manufacturing Operations 2004-2006
Managed the formulation development and day to day operations of proprietary sur
factant projects in our manufacturing facility. Formulated and recommended manuf
acturing policies, procedures and programs to expedite the manufacturing process
within cGMP guidelines. Training and assisting personnel in the production proc
ess as well as inventory and facility management.
* Developed new operating procedures for the day-to-day operation of the Sustain
ed Release Manufacturing Facility.
* Initiated and developed various vendor relationships to ensure that all produc
tion and shipping processes were able to meet critical clinical and development
timelines.
* Coordinated the preparation of documentation and data for FDA and EMEA pre-ins
pection and inspection audits for the facility and proprietary products.
* Developed streamlined process for assembly of reactor vessels reducing time sp
ent on setup of production runs.
* Coordinated the validation of the SIP, CIP, autoclave processes and Hamo wash
cleaning verification.
* Directed the process operation and monitored the operators to ensure adherence
to cGMPs and operational protocols.
* Assisted in the re-design of the operations facility in accordance with EMEA a
nd FDA requirements for NDA approval of proprietary surfactant product.

LAUREATE PHARMA INC. Totowa, NJ

Manager-Parenteral Manufacturing Formulation and Filling 2003-2004
Manage the formulation development and day to day operations of client company p
rojects in our manufacturing facility. Formulate and recommend manufacturing pol
icies, procedures and programs to expedite the manufacturing process within cGMP
guidelines. Responsible for managing all personnel requirements, and training f
or the clients' production schedules.
* Developed new operating procedures for the day-to-day operation of the Sustain
ed Release Manufacturing Facility. Assisted in the technical transfer of manufac
turing procedures from clients.
* Directed and managed the development, planning, implementation and maintenance
of manufacturing methods, processes and operations for new and existing product
s and technologies.
* Coordinated with clients and product development partners to develop, scale-up
, and manufacture bulk formulations by providing technical support on behalf of
the Extended Release Technologies Division.
* Coordinated the preparation of documentation and data for FDA pre-inspection a
nd inspection audits for client's/our products.
* Marshaled the facility changes to meet FDA and EMEA requirements and requests,
to achieve NDA approval.
MERCK & COMPANY, INC. West Point, Pa
Supervisor -Viral Vaccine Production Bulk Manufacturing 2001-2003
Supervise 55 process technicians in the manufacture of the Varicella Virus Vacci
ne and coordinate with other departments to ensure that all processes and enviro
nmental conditions are within current quality, and cGMP requirements. Ensure tha
t all activity is disseminated among all management personnel across various shi
fts.
* Investigated all Atypical Process Reports (APRs) and resolved all outstanding
issues through corrective actions so that the batches can be released.
* Processed all harvested lots components and bulk into IMPACT (Inventory, Manuf
acturing, Accounting,
Control and Tracking System) to close for departmental financial accountability.
* Trained all Technicians in the use of the IMPACT system and proper procedures
in the process of propagating, infecting, and collecting live mammalian lung cel
ls.
* Supervised operations on Cell Side (propagating mammalian lung cells for infec
tion) and Virus Side (process of final propagation and infection of those cells
prior to freezing) in our aseptic core.
Supervisor -LYO Operations 1999 - 2001
Direct all production related activities in the manufacture, filling, sealing, i
nspection, and packaging of lyophilized vaccines. Supervise employees (80) inclu
ding scheduling, and training on aseptic procedures in the GMP area.
* Responsible for the proper operation of all product equipment to include exped
iting equipment repairs,
decisions and direction as to what repairs are needed, taking alternative, cor
rective actions when needed.
* Monitored equipment operation during filling/liophilization and seal/inspect/p
ackaging and daily communication with other supervisors, managers and area heads
to ensure that all critical timelines were achieved.
* Coordinated with support departments, to reduce equipment downtime and decreas
e response time for technical issue resolution.
* Monitored the filling and Lyo equipment to ensure that all required operation
parameters were met.
YOH SCIENTIFIC, INC. West Point, Pa
Merck & Company, Inc. - Biological Manufacturing Engineering Support Department
1998 - 1999
Project Engineer
Develop, identify and collect all equipment specification in all biological proc
ess areas. Create current P&ID drawings for all equipment in the process rooms a
nd enter data into new maintenance data base Maximo. Assist other engineer supp
ort group personnel where needed in the support of all biological manufacturing
areas.
* Assisted in data collection and Hazop for the production start-up of the Menin
gitis Fermentation Suite.
* Developed emergency material bank with vendor for 24/7 support of vaccine prod
uction areas.
* Performed IQ/OQ's for all relocated equipment in Building 34 during building r
enovations.
* Created, revised and verified P&ID drawings for all of the biological producti
on areas and coordinated the collection
and organization of equipment data for the preventative maintenance data
system being installed.
* Coordinated with Central Engineering the update and revision of the Infrastruc
ture Project Utilities for the animal facility.
EDUCATION/ ASSOCIATIONS
The University of Pittsburgh, Johnstown, Pa
Bachelor of Arts in Political Science
Bachelor of Arts in Sociology
Member of the Parenteral Drug Association
Member of the International Society for Pharmaceutical Engineers
Member of the American Association of Pharmaceutical Scientists