Manager Manufacturing

Title:Nikhil Shah

**********.**@*****.***

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Name: nikhil shah

Address:

City: monmouth junction

State: NJ

Zip/Postal Code: 08852

Country:

E-mail: **********.**@*****.***

Primary Phone:

Background

Most Recent Job Title: Supervisor / Manager manufacturing

Most Recent Employer: Sanofi aventis

Career Level: Manager, Director Level

Availability or Timeframe: Immediately

Authorized to work in the US: Yes

Security Clearance:

Do you have transportation: Yes

Over 18: Yes

Education: Masters

Languages Spoken: English

Job Preferences

Desired Salary: Open

Willing to Relocate: United States

Desired Job Titles: Manager

sr manager

Desired Job Types: Employee

Work Status: Full Time

Desired Shifts

: 1st Shift

Desired Travel: 10%

Category: Engineering and Research, Manufacturing/Industrial, Operations

Company Size:

Company Type:

Industry: Biotechnology, Manufacturing / Production, Pharmaceuticals

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Copyright c 1997- Lee Hecht Harrison, Inc.

Nikhil Shah

2802 Sugar Maple Ct

Monmouth Junction; South Brunswick, NJ 08852

H: 732/940.4165

**********.**@*****.*** M: 732/742.2461

Manufacturing Manager

Manufacturing Manager and leader of API manufacturing activities. Experience working in

pharmaceutical and chemical manufacturing environments. Strong background in managing

process development, production planning, inventory control, and technology transfer from

R&D to commercial scale.24 years of diverse management and hands-on experience including

matrix environments; leading and collaborating multifunctional teams. Qualifications

include:

Worked with USFDA / TGA compliant API and clean room manufacturing facilities and

auditing of facilities.

Detailed knowledge of safety-related chemical manufacturing, environmental protection.

Worked and led oral, sterile, lyophilized, and clean room environments.

Project management, process engineering, process development, plant maintenance, safety,

quality initiatives.

Experience working in union environment.

Professional Experience

Sanofi Aventis Ltd

., Bridgewater, New Jersey 20062010Supervisor / Manager

- Manufacturing

Hired to build up pilot plan, which produces Active Pharmaceutical Ingredients for

clinical trials. Responsible for production planning and inventory control, GMP

compliance, new equipment validation and I.Q, O.Q and P.Q for equipment. Developed new

vendors and cost control initiatives. Effectively managed budget and available resources

for optimum utilization of shop floor facility, including preventive maintenance.

Team leader for Operations segment of technology transfer from chemical development lab

for scaling up new products successfully for clinical trials, waste management and co

ordination with other departments. Transferred approx. 25-30 products with complicated

chemistry and multiple steps successfully while working with demanding and matrix

environment.

Led safety audit team, generating and distributing monthly reports and ensuring

compliance from all the responsible departments in timely manner. Always ensured safe

working environment and an excellent G.M.P compliance.

Member of internal G.M.P compliance and Q.A audit team for monthly auditing for chemical

development, pilot plant and chemical analytical lab.

Nectar Life Science Ltd

., India 20042005General Manager, Chemical Manufacturing

Led a group of 350 professionals in chemical manufacturing operations of sterile, non-

sterile, and oral APIs such as Cefixim, Cefuroxime Axetil, Cefpodoxime Proxetil, Cefepime,

and related intermediates. Accountable for safety as well as environmental protection.

Improved productivity 20% (from $50 million to $ 60 million) by improving cycle time,

eliminating bottlenecks, reducing unplanned stoppages through establishing 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.

Nikhil Shah

**********.**@*****.*** Page 2

Orchid Chemicals and Pharmaceuticals, India 20012004Production Manager

Led manufacturing activities for $60 million manufacturing facility, outsourcing

intermediates, and auditing activities. Core competencies in the development and

manufacture of Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms as well

as in drug discovery. Handled production of 7 ADCA-based APIs Cephalexin, 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 non-

compliance.

Spearheaded substantial reduction 8% ($6 million) in production cost achieved through

improving solvent recovery and reducing solvent loss during processing.

Team achieved ISO9001 and ISO14001 certification.

Rubamin Pharmaceuticals, India 19992001Deputy General Manager

Handled multi-site factory operations; oversaw manufacturing of custom synthesized

chemical products and intermediates for ISO9001, ISO14001 accredited manufacturer of

Pharmaceuticals and Fine Chemicals. Export Oriented Unit (EOU) focused on R&D, operations,

supply chain, and marketing for complex chemistry issues.

Managed continuous technology transfers from R&D as well as from overseas partners by

working 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 control functions

and reducing unplanned production stoppages by ensuring effective preventive maintenance

initiatives were in place.

Unimark Remedies Ltd

., India 19981999Plant Manager

Directed production of APIs as well as Quality Control and Quality Assurance functions

for Albendazole and Nimesulide products. Group turnover was approximately $50 million.

Established quality systems for new production facility.

Concord Pharmaceuticals, India 19921998

Subsidiary of HOECHST Pharmaceuticals and Max-GB Ltd

[1992 to 1998]

Production Manager

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 Trihydrate, Cloxacillin Sodium, Cephalexin, and

Intermediate 6 APA.

Education

Master of Science,

Organic Chemistry, Gujarat University, India

Bachelor of Science,

Chemistry, Gujarat University, India

Post Graduate Diploma

in Business Management, All India Management Association

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