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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.