Project Manager

SANJAY SAMUDRE

**, ***** ***** ***** ************, Tennessee 37334

Tel: 931-***-**** / 256-***-****

Email: *************@*****.***

PROFILE

A talented Operations Management Specialist with strengths in fostering

teamwork, leadership, trouble shooting, problem solving and overcoming

technical challenges. Highly adept at motivating and empowering team to

create and optimize their effectiveness, efficiency and achieving common

goals. In-depth knowledge of the pharmaceutical industry and proven ability

to provide creative and logical solutions.

EMPLOYMENT HISTORY

QUALITEST PHARMACEUTICals, Huntsville, Alabama

2008 - Present

Privately held, Qualitest has its headquarters and distribution facilities

in Huntsville, Alabama, with workforce of over 900 employees Qualitest

provides affordable, high-quality generic pharmaceuticals. Featuring a

current portfolio exceeding 600 products,and is now ranked in the top ten

among all suppliers of generics, based on total prescriptions filled.

Production Manager - Liquid Manufacturing/Filling/Packaging -

Providing Leadership, Coaching and Mentoring to 3 direct reports

(Supervisors) and 110 indirect key operations team member.

As a key member of Management, currently providing leadership for

successfully implementing change in cultural paradigm to production

associates.

Providing a clear Vision to associates within production department which

is aligned with company Vision and successfully collaborating with support

departments for cost effective operations.

Identifying key associates within the production department for personal

and professional development and creating ownership within the process

amongst the team members.

Identifying and Implementing systems within the department for production

associates to attain higher standards of safety, quality and productivity

which are aligned with company goals and objectives.

Encouraging employee involvement and feedback for identifying non value

added steps

Initiated cross-functional partnership to identify and resolve production

challenges

Collaborating with associates within production department to ensure SOP's

are well defined along with identifying and implementing the training needs

of associates.

Ensuring timely closures of non conformances along with identifying and

implementing effective CAPA.

Currently involved in design phase for facility upgrade project to be at

par with industry standards.

Successfully implemented efficiency improvement project

Identified and eliminated non value added steps within the packaging

process which resulted into better utilization of 3 packaging

personnel/shift with total savings of approximately 200,000/year including

labor and material.

Increased uptime by approximately 10-15 % through employee involvement by

stream mapping the packaging process.

Developing and tracking of department metrics and performing variance

analysis for improvements.

CIBA VISION STERILE MANUFACTURING, Mississauga, Ontario

2004 - 2008

A Novartis Company

Ciba Vision is the eye care unit of Novartis AG, a global group of

companies headquartered in Basel, Switzerland employing 100,000 People in

140 countries around the world with sales of USD 28.2 plus billion.

Production Manager - Aseptic Manufacturing/Filling/Packaging - Sterile

Lens/Eye Care Products

Facilitated, Coached and Mentored 5 direct reports (Group Leaders and Team

Leaders) and 40 indirect key operations team members on an operational

budget of $ 5,000,000 and annual capital expenditure of $1,500,000 to

$3,000,000.

SANJAY SAMUDRE

As a key member of the Management, Facilitated the Production associates

towards being a successful Self Directive Work Force.

As a key member of the design team ensured the final quality standards of a

major facilities renovation project, by providing deviation and deficiency

analysis for the team.

Lead and coached key production team to meet stretch targets for on time

delivery to the Global Supply Chain in accordance with cGMP, TPP, FDA, EU

and ISO guidelines.

Identified, recommended and implemented continuous improvement projects in

production areas by performing root cause analysis and creating short and

long term solutions which have improved production efficiency and quality.

Participated in identifying and closure of minor gaps in production and

successfully implemented and managed CAPA quality systems.

Managed short and long term budget ($5,000,000) that includes: human

resources, facilities and equipment upgrades for production department.

Involved in Lean Manufacturing and FAR(Kaizen) projects

Reduced Cleaning and Disinfection time of sterile rooms by 10-15 %.

Involved in low volume project resulting in reduction of ~1.1 % to 0.55 %

low volumes with annual savings of +$150,000.

Involved in Double filter housing project resulting in annual savings of +

$ 200,000 due to decrease in downtime due to CIP/SIP resulting in increased

production.

Involved on case packing project + $500,000 to reduce labor (4 operators),

increased efficiency by 25%, and improved safety on 2 packaging lines.

Reduced labor (1operator/shift) by executing FAR (Kaizen) project resulting

into a annual savings of + $100,000

Increased production by 10% through value stream mapping all packaging

processes and eliminating non-value added process steps.

Eliminated unscheduled downtime by initiating and developing a master

scheduler which ensures the proper flow of raw materials and timely

communications with supporting departments.

Researched, developed and presented Leadership Training Program for all

production team leaders throughout the department.

Set Objectives aligned to Company Objectives, regularly appraised progress,

coached and developed performance.

Ensured communication of trends and significant events with the Director

with a view for enhancing over all departmental performance.

PATHEON INC, Mississauga, Ontario

2000 - 2004

Patheon is a leading global provider of outsourced drug manufacturing and

development services to pharmaceutical and biotechnology companies

headquartered in Mississauga, Canada employing more than 5,800 providing

services at 14 facilities in North America and Europe.

Associate Process Development Engineer- Process Development (2001 - 2004)

Managed 6 technical and non technical staff for scientific and technical

activities of both Pharmaceutical development services and manufacturing.

Maintained expert knowledge of equipment, instrumentation, procedures and

scientific methodologies necessary to perform the tasks.

Prepared Master Batch Records for proper execution of Clinical Trial

manufacturing, Validation and Registration batches. Evaluated and

summarized data.

Reviewed, instrumentation or production / processing documents and SOPs.

Communicated with supplier's manufacturers and vendors to get samples and

detailed description of excipients and equipment.

Process Development Technologist - Process Development (2000-2001)

Worked under Guidance of Associate Process Dev Eng. to optimize parameters

for process improvements.

Optimized process & equipments for validation & registration batches.

Performed trials for solid dosage forms for feasibility, clinical trial and

registration batches.

SANJAY SAMUDRE

Monitored scale up, validation & registration batches. Technical support

for production batches

APOTEX INC, Toronto, Ontario

1998-1999

Apotex is largest Canadian Pharmaceutical Company with 5,300 plus employees

headquartered in Toronto, Canada with total sales of CAD $1.0 Billion

through out 115 countries over the world.

Production Technologist - Antibiotic Plant

Worked as a team player within the manufacturing department under minimal

supervision.

JOHNSON AND JOHNSON LTD, Bombay, India.

1994-1998

Johnson and Johnson is the world's most comprehensive and broadly based

manufacturer of health care products headquartered in New Brunswick, USA

employing 113,800 people around the world with sales of USD 47.3 billion.

Senior Production Officer - Consumer Product Division

Directly supervised and successfully managed 30 unionized production staff.

EDUCATION AND PROFESSIONAL DEVELOPMENT

Facilitation Development Program- The Flying Starship Factory 2010

Effective Systems Limited. - Houston, TX

Leadership Development Program - Leading Change 2009

Qualitest Pharmaceuticals - Huntsville, AL

Certificate of Equivalency : BSc with major in Pharmaceutical Sciences

2008

Educational Credentials Evaluators, Inc. - Milwaukee, WI

Leadership Training: Leading with Vision 2007

Novartis Management Development Program- Atlanta, GA

Workshop : Microbiology Fundamentals for the Pharmaceutical 2007

Industry Workshop.

Academy of Applied Pharmaceutical Sciences. - Toronto, Canada

Team Building Retreat, Strategic Planning/ Team Alignment

2007

Corporate Quest. - Algonquin Park, Canada

Leadership Training : Leadership Development Program 2007

Development Dimensions International (DDI). - Toronto, Canada

Six Sigma Lean Manufacturing Training 2007

Ciba Vision. - Toronto, Canada

Fast Action For Results (KAIZEN) 2007

Ciba Vision. - Toronto, Canada

Clean room Microbiology Workshop 2007

PDA Research and Training Institute. - Bethesda, MD

Management Training 2004

The Beacon Group. - Toronto, Canada

Certificate: Industrial Pharmaceutical Technology Certificate

2000

Seneca College - Toronto

Certificate of Equivalency : Evaluated by University Of Toronto

1998

University Of Toronto

Degree : Bachelors in Pharmacy 1994

University Of Pune - India

References available upon request

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