Sadath U.

Khan
6 Mariner Drive
Randolph, NJ 07869-1252
Home Mobile
Telephone number: 973-361-8486 201-787-7592
e-mail address: skfd4f46@westpost.net

Career Profile
A senior executive with proven success in technical, administrative, entrepreneu
rial, leadership, and technical negotiation competencies in managing key global
pharmaceutical, consumer healthcare and OTC products R&D departments, contract
research and manufacturing organizations. Encompasses broad based technical exp
ertise in managing technical negotiation strategies in global new product launch
es, contract manufacturing & research organization evaluation, and product sourc
ing, GMP compliance management and auditing, compliance with monograph specifica
tions, analytical/microbial testing, pre-formulation, formulation and process de
velopment, clinical and commercial manufacturing & packaging, scale-up, technolo
gy transfer, validation and launch of new ethical pharmaceutical and consumer he
althcare dosage forms (immediate/timed/sustained release tablets, capsules, oint
ment, cream, oral liquid/suspension/emulsion, and thin edible films) and claims.
Well versed in preparing/updating the CMC, developing regulatory strategies and
variance and managing post approval manufacturing/SUPAC changes and strategical
ly interacting with global regulatory authorities supporting in-house Regulatory
Affairs department. A skilled leader in managing and guiding direct reports an
d contract facilities in identifying cause and trouble shooting manufacturing va
riability; and instituting suitable controls promoting high quality attitude in
the manufacture of commercial products. A business oriented and strategically r
esponsive leader with competency in organizing, negotiating, leading and adminis
trating multi-disciplined personnel and departments globally, including coordina
ting and managing outsourced organizations for Formulation & Process Development
, GMP compliance, Clinical Manufacturing, Project Management, Analytical, Microb
iology, Packaging activities. Demonstrated ability to work with global affiliate
s across multi-functional groups ensuring most streamlined processes in bringing
product from conceptual phases to commercial launch effectively meeting cost co
ntainment, regulatory compliance and business strategies and goals. A highly re
sourceful and proficient leader in planning and managing department budgets and
inter/external resources. A pleasant mannered leader with excellent inter-perso
nnel, communication and risk assessment and management skills.

Education
Ph.D. in Pharmaceutical R&D, Strafford University, London, England.
MS in Industrial Pharmacy, Massachusetts College of Pharmacy, Boston.
BS in Pharmacy (B. Pharm), Bangalore University, Bangalore, India.

Experience
March 2009 to October 2009: Vice President
Global Pharmaceutical Sciences
ProStrakan Pharmaceuticals, Bedminster, New Jersey. (a Scotland based company).
Principal Responsibility: Managed and lead global formulation development, proce
ss development, analytical method development, clinical trial supplies manufactu
ring & coordinating, technology transfer, stability studies and provided technic
al support to the Regulatory Affairs for the Chemistry, Manufacturing and Contro
ls (CMC) sections, writing, reviewing and guiding in organizing modules 2 and 3
for NDA sections. Provided guidance in QbD techniques and design of experiments
 for quality and reliability in clinical and commercial manufacturing. Identify
, make technical & quality assessments and manage contract research and manufact
uring organizations globally assuring high quality products. Contribute to devel
opment of phase III dossiers with US (FDA) and European (EMEA) Regulatory agenci
es. Develop/rationalize post approval filing strategies, variance, and manufa
cturing/analytical method changes. Provided guidance ensuring harmony with ICH a
nd other regulatory guidance. Provided guidance and technical assistance in the
compilation of responses to the global health authorities. Developed and manag
ed departmental budgets, resources. Planned and managed departmental, internal a
nd global resources including outsourced organizations supporting and assuring c
GMPs, and timely supply of products for global clinical/investigational studies
and launch of all new products (tablets, capsules, cream, ointment, injectable a
nd transdermal patches for the treatment and management of pain, diabetes and on
cology diseases). Recruited and managed direct reports globally (US and Europe).
Accomplishments:
- Managed filing and approval of one NDA
- Filed three more NDAs.
- Addressed several technical manufacturing and formulation issues globally.
March 2008 to March 2009: Director
Pharmaceutical Technology
Merial Limited (Animal Healthcare division of Merck)
Principal Responsibility: Managed and led process development, scale-up, clinica
l manufacturing and technology transfer activities for animal healthcare pharmac
eutical products to internal and contract manufacturing facilities in the USA, C
anada, Europe and Brazil. Developed and managed departmental budgets, resources
(human and facility/equipment). Plan and manage departmental, internal and glob
al resources including outsourced organizations supporting and assuring cGMPs, a
nd timely supply of products for global clinical/investigational studies and lau
nch of all new products and claims.
2000 to 2008: Director
Pilot Plant Operations
Pfizer (in 2008 became division of Johnson & Johnson) Consumer Healthcare R&D
Accomplishments:
* Strategically led global R&D teams comprised of various functional representat
ives from North America (including Puerto Rico & Canada), Europe and Contract Re
search Organizations (CRO) and Contract Manufacturing Organizations in formulati
on development, scale-up, clinical supply manufacture, technology transfer, laun
ch and commercial manufacture of the following business strategic products in a
timely manner and strategically streamlined the development process by introduci
ng technological measures noted below:
o Provided technical and directorial support in revising formulations substituti
ng the drug substance and/or enhancing manufacturing processes and assuring mono
graph compliance for Sudafed PE (tablets and thin edible films) Benadryl PE(R),
Benadryl PE SR(R), Zantac(R), Bengay(R) (cream and patches), Neosporin(R), Lubri
derm(R), Caladryl(R), Visine(R), Desitin(R), Cortizone(R), Listerine, and, Rolai
ds, to name a few.
o Innovatively designed, constructed, installed and implemented a pilot-scale th
in film manufacturing equipment for formulation & process development, clinical
supplies manufacturing and scale-up activities, which resulted in resource (time
, money and human) and business enhancement.
o Planned, designed, and led pre-formulation initiatives for API characterizatio
n and drug-excepient interaction studies eliminating primitive trial & error app
roach which resulted in the development of robust formulations, minimized rework
/formulation revision and enhanced launch and commercialization time.
o Held leadership role in negotiating with internal and external vendors and tec
hnical leaders in managing the design, upgrade and qualification of a GMP facili
ty for Johnson & Johnson meeting the regulatory requirements for the manufacture
of clinical/investigational supplies and batches used in regulatory submissions
.
o Spearheaded and organized compliance group in writing procedures (SOPs, Work I
nstructions, protocols, etc.) for the renovated J&J GMP facility.
o Spearheaded a global team for strategically planning and renovating the Pilot
Plant improving efficiency and potential for 1/10th scale batch scale-up capabil
ity, which enhanced global capabilities in cGMPs, process development, scale-ups
, and investigational supply sourcing which resulted in positive business impact
in reducing cost and time in global development and commercializing of robust f
ormulations.
o Conducted perspective business analysis. Developed working guidelines and impl
emented pivotal strategic actions addressing few chronic technical, business and
GMP issues that prevailed in the Pilot Plant and Warehouse. These actions have
resulted in enhanced capabilities with respect to cGMP compliance and work effi
ciency.
o Demonstrated ability in addressing global ambiguity by making long term global
strategic planning and leadership decisions in designing and building a unique
pilot scale film casting and drying equipment (won Pfizer Global Innovation Circ
le award) and buying new and innovative equipment for existing and innovative do
sage forms that resulted in significant global business inspirational and cost i
mpacts on Pfizer Consumer Healthcare and Pharmaceutical R&D.
o Provided strategic guidance to project management, outsourcing, analytical, mi
crobiology, product development and quality compliance functions resulting in su
pporting development and launch of several major projects and claims meeting or
exceeding divisional goals.
o Developed and implemented guidelines enhancing in-process sampling and testing
and process development procedures (PAT), cleaning validation procedures, which
were globally recognized and adapted.
o Played key roles in the development and implementation of global business impe
rative procedures, such as "New Product Development time reduction", "Career Lad
der Development", and "Job Description".
o Took global leadership role in managing global team in the development of prod
uct co-development strategies with technical (product/process development, clini
cal, regulatory and CMC functions) and business (marketing and manufacturing sit
es leaders) stakeholders resulting in streamlining the product development from
conception to commercialization.
Principal Responsibility: Managed a team of 40 high caliber scientific personnel
and an administrative assistant. Provided strategic directions, prepared and im
plemented strategic plans, and operating, capital and expense budgets. Interfac
ed with senior management and global business partners in accomplishing division
al goals and making significant business impact on R&D and across Pfizer. Plann
ed and managed departmental, internal and global resources including outsourced
organizations supporting and assuring cGMPs, and timely supply of products for g
lobal clinical/investigational studies and launch of all new products and claims
. Provided technical support in assigning cause and trouble shooting manufactur
ing problems; and in instituting operational/technical controls ensuring robustn
ess. Developed and implemented short and long term strategic plans for the depar
tment that are in alignment with Pfizer imperatives. Directed, managed and led t
he Pilot Plant Operation departments comprised of development/fine-tuning and op
timization of Formulation & Manufacturing Processes, Technology Transfer, Valida
tion/Commercialization, Clinical Manufacturing, Clinical Packaging Operations, P
roject Management, Quality Compliance, Outsourcing, Warehouse, Analytical, Micro
and Raw Materials Testing functions. Reviewed and appraised organizational capa
bilities of contract research and manufacturing organizations and provided techn
ical recommendations to Pfizer business legal groups. Guided my team in providin
g technical support to the Regulatory Affairs in the development CMC dossier. M
ade organizational decisions and provided technological directions ensuring seam
less transfer and commercialization of robust formulations and manufacturing pro
cesses for consumer healthcare products, including, tablets, capsules, liquids,
ointments, creams and lotions. Provided leadership integrity to global manufact
uring sites while fostering seamless technology transfer that complies with Co-D
evelopment curriculum. Interfaced and maintained a close liaison with Pfizer gl
obal affiliates achieving interdependent divisional goals.
1986 to 2000: Senior Research Associate/Team Leader
Product and Process Development, Pfizer Global R&D
Accomplishments:
* Developed/Revised and optimized formulations and manufacturing processes, manu
factured clinical supplies, scaled-up and supported CMC, IND / NDA / ANDA filing
s, PAIs, and commercialization of several Rx and OTC solid, liquid, film (strip)
oral dosage and topical formulations.
o Held leadership responsibility in the development through commercialization of
Accupril(R), Accuteric(R), Omnicef(R), Neurantin(R), Lipitor(R), Caduet(R), Pro
can(R) SR, and Easprin(R).
o Provided strategic technical and administrative guidance for revising formulat
ions and/or manufacturing processes addressing technical issues with dissolution
and manufacturing for Dilantin(R), Lopid(R), Myadec(R), Zarontin(R) and Celonti
n(R).
o Reformulated substituting the drug substance and/or revising the release kinet
ics for calcium valproate SR and chewable, and Benadryl PE tablets.
o Took leadership role in organizing and coordinating global Product Development
teams comprised of Product/Process Development, Analytical, Clinical, Regulator
y, Manufacturing and Project Management groups from North America (including Pue
rtoRico), Germany, and England in the development and launch of business critica
l products- Caduet(R) & Omnicef(R).
Primary Responsibilities: Managed a team of professionals and high caliber scien
tific personnel locally and globally in the development of formulations taking f
rom pre-formulation phases to market-image formulations, scale-up, clinical manu
facturing, technology transfer, validation to commercialization. Developed and i
mplemented protocols for scale-up, technology transfer, process validation, and
new pharmaceutical (Rx) product/formulations introduction to Pfizer global manuf
acturing sites. Reviewed, audited and verified protocols, batch records, analyt
ical records and other documents ensuring compliance in technology transfer. De
signed experiments for cleaning verification and validation. Designed experimen
ts, directed and provided technical and administrative guidance to my direct rep
orts in conducting experimental trials in the development of robust formulations
and manufacturing processes for solid dosages feasible for scale up and commerc
ialization. Provided technical guidance in assigning causes and trouble shootin
g routine manufacturing problems.
Project Team Leader: Coordinated with various global divisions of Pfizer in faci
litating and providing directions and leadership in formulation development and
technology transfer activities of new products. Regularly and systematically co
nducted and led project team meetings to ensure that all activities and appropri
ate line functions understood the project goals and timelines are being confluen
t with corporate objectives.
1983 to 1986: Research Associate Scientist
1981 to 1983: Senior Pharmaceutical Technologist
1978 to 1981: Scientist
1976 to 1978: Associate Scientist
Parke-Davis, Division of Warner-Lambert
Primary Responsibilities: Managed a team professionals and high caliber scienti
fic personnel. Participated hands on and provided guidance in immediate and sus
tained/timed release formulation development, optimization, scale up, clinical m
anufacturing, and technology transfer of solid oral dosage formulations in-house
and contract manufacturing sites.
1972 to 1974: Manager, Formulation Development and Manufacturing
Denison Laboratories, Inc., Pawtucket, Rhode Island
Primary Responsibilities: Developed formulations for OTC liquid, solid oral dosa
ge and semi-solid pharmaceutical preparations..

1970 to 1972: Manufacturing Technologist

Smith, Kline & French (India) Ltd., Bangalore, India.

Publications, Presentations and Patents

* More than 20 technological publications/presentations.
* 10 patents excluding the 2 pending applications.