NIKHIL SHAH

2802 sugar maple ct

Monmouth Junction; South Brunswick, NJ 08852-4211
H: 732/940.4165 * M: 732/742.2461
nsa686d4@westpost.net
SENIOR MANUFACTURING MANAGER - Expertise in:
Active Pharmaceutical Ingredients / Chemicals / Intermediates Manufacturing
Senior Manufacturing Manager and leader of API manufacturing activities. Strong
background in managing process development, production planning, inventory contr
ol, and technology transfer from R&D to commercial scale. Background in directin
g medium-scale factory operations. 23 years of diverse management and hands-on e
xperience including matrix environments; leading and collaborating multifunction
al teams.
Qualifications include:
* Worked with USFDA / TGA compliant API, clean room and sterile manufacturing fa
cilities and auditing of facilities.
* Detailed knowledge of safety-related chemical manufacturing, environmental pro
tection. Worked in sterile, lyophilized, and clean room environments. Experience
in ISO9001 and ISO14001 certified facilities.
* Project management, process engineering, process development, plant maintenanc
e, safety, and quality initiatives.
* Excellent communication skills - verbal, written, electronic, etc. Experience
working in union environment.
* MS in Organic Chemistry / BS in Chemistry / Business Management Certification
Experience in:
USFDA & TGA Compliant Facilities / Productivity Improvement / Cost Effectiveness
/ Auditing / Process Development & Validation / Production Planning / Inventory
Control / Continuous Improvement / Cross-Functional Teams / Efficiency Improvem
ent / Environmental Health & Safety / Pilot Manufacturing / Multi-Site Operation
s / Operating Budget / Plant Operations / Kilo Lab Manufacturing
PROFESSIONAL EXPERIENCE
Sanofi-Aventis Ltd., New Jersey ; 01/06 to present
Currently functioning as Supervisor in Pilot Manufacturing Plant facility (third
largest pharmaceutical in the USA), producing APIs for clinical trials. Respons
ible for production, waste management, leading safety team and technology transf
er along with budgeting. Hands on shop floor working and managing. This is my fi
rst job in USA after immigration with family.
NECTAR LIFE SCIENCE LTD.; India
General Manager, Chemical Manufacturing * 2004 to 2005
Responsible for chemical manufacturing of sterile, non-sterile, and oral APIs su
ch as Cefixim, Cefuroxime Axetil, Cefpodoxime Proxetil, Cefepime, and related in
termediates. Led a group of 350 professionals manufacturing operations. Accounta
ble for safety as well as environmental protection.
* Improved productivity 20% (from $50 million to $ 60 million) by improving cycl
e time, eliminating bottlenecks, reducing unplanned stoppages through establishi
ng preventive maintenance schedules, stabilized production planning, and ensured
accurate inventory control.
* Improved overall solvent recovery (4%) by upgrading efficiencies at all stages
of operations and ensuring tight control over supporting systems. Increased pro
ductivity by 15%; decreased production cost by 5%.
* Brought effectiveness in manufacturing by implementing employee participation
changes in all operations.
ORCHID CHEMICALS AND PHARMACEUTICALS; India
Production Manager * 2001 to 2004
Led manufacturing activities for globally recognized, integrated pharmaceutical
company with core competencies in the development and manufacture of Active Phar
maceutical Ingredients (APIs) and Finished Dosage Forms as well as in drug disco
very. Responsible for $60 million manufacturing facility, outsourcing intermedia
tes, and auditing activities. Handled production of 7 ADCA-based APIs- Cephalexi
n, Cephradine, Cephadroxil, and their intermediate 7ADCA in US FDA/TGA compliant
manufacturing facilities. Member of internal quality inspection team.
* Successfully engaged in two USFDA audits; FDA approved facility without any no
n-compliance.
* Spearheaded substantial reduction - 8% ($6 million) in production cost - achie
ved through improving solvent recovery and reducing solvent loss during processi
ng.
* Team achieved ISO9001 and ISO14001 certification.
RUBAMIN PHARMACEUTICALS; India
Deputy General Manager * 1999 to 2001
Handled multi-site factory operations; oversaw manufacturing of custom synthesiz
ed chemical products and intermediates for ISO9001, ISO14001, and OHSAS 18001 ac
credited manufacturer of Pharmaceuticals and Fine Chemicals. Export Oriented Uni
t (EOU) focused on R&D, operations, supply chain, and marketing for complex chem
istry issues.
* Managed technology transfers from R&D as well as from overseas partners by wor
king at their overseas manufacturing / pilot plant facilities.
* Stabilized new production site for manufacturing custom synthesized products.
Improved work-related safety issues by constant training and auditing.
* Improved productivity by revitalizing production planning and inventory contro
l functions and reducing unplanned production stoppages by ensuring effective pr
eventive maintenance initiatives were in place.
UNIMARK REMEDIES LTD.; India
Plant Manager * 1998 to 1999
Directed production of APIs as well as Quality Control and Quality Assurance fun
ctions for Albendazole and Nimesulide products. Group turnover was approximately
$50 million.
* Established quality systems for new production facility.
CONCORD PHARMACEUTICALS (subsidiary of HOECHST Pharmaceuticals and Max-GB Ltd) [
1987 to 1998]; India
Production Manager * 1992 to 1998
Responsible for total factory operations and production and process development
activities involved in manufacturing antibiotic bulk drugs along with acceptable
quality and delivery logistics. Headed all plant maintenance for GMP compliant
facility and systems. Production turnover was $30 million.
* Handled production of APIs, mainly of Antibiotics such as Ampicillin, Trihydra
te, Cloxacillin Sodium, Cephalexin, and Intermediate 6 APA using enzymes.
* Joined corporation as Production Officer in 1987, steadily increased responsib
ilities, and ultimately promoted to Production Manager.

EDUCATION CREDENTIALS
Master of Science degree in Organic Chemistry - GUJARAT UNIVERSITY, India
Bachelor of Science degree in Chemistry - GUJARAT UNIVERSITY, India
Post Graduate Diploma in Business Management - All India Management Ass