Project Manager

Shaailesh Gokhale.

A/***, Meghvarsha, Mumbai- Bangalore Highway, Near Mai Mangeshkar Hospital,

Warje, Pune, INDIA- 411058.

Contact: +912*****-****.

Mobile: +919*********.

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

Skills Summary

Senior Manager - Project & Engineering with experience in Pharma, API, and

Biotechnology Project development. Skilled in Project Management, Layout

Detailing, Pharma formulation and API unit Machinery, HVAC system, & Water

system & other utilities such as Boiler, Chiller etc. Excellent background

in pharmaceutical, API, chemical synthesis manufacturing facility design,

detailing with it's Maintenance.

Also experienced in Pharmaceutical, API, Chemical synthesis & Biotechnology

projects & Maintenance related documentation as per international

regulatory agencies such as USFDA, MHRA, MCC etc.

Faced successfully international regulatory audits such as USFDA, ANVISA,

MHRA & TGA as an Engineering Team Lead.

Also expertise in man power handling, contractor co-ordination, negotiation

with the vendors & other commercial aspects.

Expertise in Project Management tools like MS Project and PRIMEVRA.

Specialties:

. Techno-commercial negotiations for terms sheets, contracts &

agreements with major contractors, vendors, consultants and

clients.

. Alliance management with global MNC clients from a technology,

process, project and fiscal perspective.

. Fiscal management and cash flow forecasting for major capital

investments.

. Analyzing and developing programs to enhance technical and soft

skills for the team.

. Ability to put together a cohesive unit with cross functional

expertise.

. Set up processes to initiate dialog with the regulatory agencies

for pre-inspection discussions for new investments.

. Developing a master plan for the future facilities is one of my

important responsibilities & Specialty. Designing the Facilities of

Tomorrow.

. Overcoming perpetual challenges in areas of technology, regulatory

and economics

. Comparing various design philosophies and factoring in cost

considerations

. Weighing the need for intelligent devices and automation and how

they can enhance your manufacturing processes

. Process scale-up, Bioreactor design

. Project Management tools-MSP & PRIMEVRA.

Employment

Senior Manager - Projects & Engineering.

BIOCON Ltd. -Bangalore

May 2007 - Till Date

My group is responsible for design, construction and start-up

commissioning, qualification and validation of Facilities for Research &

Development, Biologics Manufacturing, Chemical synthesis, Vivarium,

Clinical and Bio-analytical research facilities. As the Project Leader, it

is my responsibility to develop and enable the implementation of systems

for effective Project Management and to evaluate, negotiate and award

contracts to Design Engineering & Architectural Consulting companies,

Construction management companies, Process Equipment vendors, Automation &

Instrumentation vendors, Structural, Civil, Clean room partitions, HVAC and

Central plant utility equipment & Piping vendors apart from Clean/Pure

utilities generation and distribution contractors. Evaluating geographical

expansion opportunities for growth and developing a master plan for the

future facilities is one of my important responsibilities.

The Important responsibility is to co-ordinate with various Project group

and stake holder for their deliverables and communicate to management for

respective project progress and then take up-to final conclusion.

This also includes work closely with research groups to identifying risk

involve in various project, analyzed and prepare pan-B OR contingency plan

ready for execute if needed.

Help to various research group to De-bug all hurdles and identify various

resources (internal OR external) and help them drive the project to logical

conclusion.

Also Helping Group to identify and eliminate various non-value added

activities and operation with using LEAN technique.

Worked on Projects; for BRISTOL MYERS SQUIBB (Joint Venture of BIOCON &

BMS). This is RND facility for chemistry & Biology. Approx. Project

investment was 145 Cr.

This Green field Project was to accommodate approx. 400+ Scientist. These

are the labs for Chemistry & Biology with class D area and radioactive

element handling area and pilot scale chemical synthesis process unit up to

capacity of 200kg with hydrogenation process area.

The Scope is Discussion with Consultant for freezing the specifications,

design specification, preparation of equipment URS, concept detailing,

Vendor identification, Tendering, Negotiation, Ordering up to Commissioning

& Handover to Users.

Another Project is manufacturing block for Biology formulation,

Fermentation and chemical synthesis Process Plants of capacity from 1500 L

and 5000 L. The Approx. Value for this Project is 100+ Cr.

Design detailing already completed, civil construction was completed and

facility is under use for Phase-1 and Phase-II validation is in progress.

The Facility is in operation since March 2012 - Phase Manner.

This project includes a Cell culture Area and Bio analytical and other

support area for Formulation and chemical synthesis Process.

Working on another project B1X (Biological process and injectables unit),

Joint venture with European Giant. The Phase 1 construction and Engineering

activity is completed on Oct 2011 the validation process is going on for

new product.

The Phase-II will start from Jan 2013. The total Capital investment

budgeted is

45 Mn. USD.

Recently faced an FDA audit for Injectable (Vial BIOPHARMA Products) unit

as an engineering and project team lead successfully.

A team member of energy conservation team, lower down the electricity

consumption of two blocks, Manufacturing and RND.

Sr. Manager-Engineering & Projects - Paras Pharmaceuticals Ltd. Ahmadabad.

Oct, 2005- May 2007.

Worked on green field project, a facility was designed for Solid oral

dosage, liquid, cream and ointment.

The Capacity of this project is 648 Million per annum Tablet, 300 Million

tubes filling capacity in ointment section( 9 Tube Filling & sealing lines)

& 6776Kl of liquid capacity.(Phase-I)

Also having separate facility for cosmetics with three tube filling lines &

2 liquid bottle filling lines.(Phase-II) and for Powder filling Line.

The approx. project cost is 87 Cr.

This is largest Facility for ointment mfg. and tube filling at single

location in India.

Part of all the regulatory agency audits. Also responsible for

implementation and controlling of environmental control policies in the

premises.

Also handled the maintenance of this facility, leading a team size for

utility operation was 25 skilled and for plant operation with 20.

Manager - Maintenance & Projects - Cadila Pharmaceuticals Ltd.

Ahmadabad.

Sept, 2003- Oct 2005.

Worked on Ethiopia project, The facility consist of manufacturing liquid

orals, tablets, & capsules. The capacity of plant is 1.5 lacs bottles per

day, 20 million tablets per day and 2 million capsules per day. The project

cost is Rs.39 Cr.

Handled daily and preventive maintenance of solid oral dosage mfg. and

liquid injectables, and potent drugs facility situated at dholka near

Ahmadabad.

The team size of 32 engineers and 128 skilled workers.

A part of pharmaceutical regulatory committee team, handle regulatory

agencies & also handling environmental, pollution control. Successfully

handled audit for MCC, TGA, MHRA & WHO Geneva.

Also, worked on

1) Worked on API process Facility up gradation, capacity up gradation for

upstream and downstream for to meet regulatory standards (USFDA) The budget

for this project was 22 Crores.

2) A.N.D.A. tablet manufacturing facility consists of capacity-50 kgs

Pivotal/Commercial batch size. The project includes designing of layout,

estimation of budget, equipment & utility selection and commissioning of

plant.

The project cost was of 37 Cr.

3) Worked on Jammu & Kashmir Project having facilities of manufacturing

liquid orals, tablets, & capsules. The capacity of plant is 1.5 lacs

bottles per day, 180 Cr. per annum tablets per day and 6 lacs capsules per

day. The project cost is Rs.69 Cr.

4) Worked on Lyophilize vial project for US customer having capacity of 10

Mn. Vials per annum of Cepha group. Estimated project cost is 65 crores.

. Lead audit team member and successfully delivered for an audit USFDA

and ANVISA, MHRA for couple of times as an Engineering Team Leader.

. Completed WHO, ISO, MCA documentation such as URS, DQ, IQ, OQ, PQ etc.

General Pharma & Injectable & utility.

.

Cut down an electrical consumption by 10% & total energy conservation

by 15% of earlier.

. Also handling pollution control & factory inspector & pharmaceutical

regulatory agencies.

Mechanical Engineer - CIPLA LTD., Patalganga, Mumbai.

Oct, 97 - Aug 2001.

Looked after routine & preventive maintenance of utilities such as, Thermic

fluid heater, pumps, chilling plant, Air compressors, DM water plant, Pouch

pkg. M/C. Brine plant (-30 deg. C), Boiler, Pharmaceutical equipments as

Tablet Compression M/c, Capsule filling M/c, Sizoner (wet granulator),

sifter, FBD, FBP, Blenders, Autocoater, Blister / Stripe pkg. M/c,

cartnator, collator, labeling M/c, shipper collator.

. Completed projects in Goa for tablets, also completed project of Sprays

and Injectables in a target schedule. Commissioning of chilling plant, Air

compressors, D.M. water plant, Brine plant (-11 deg. C), Boiler,

Centralized A/C system, HVAC.

. Also commissioned complete Aerosol inhaler filling/ sealing & automated

with logic control packing lines.

. Prepared documentation for FDA audit for Local FDA & for other regulatory

agencies such as URS, DQ, IQ, OQ, PQ for above utility & for Pharma

equipments.

Project Leader -

Tata Honeywell, PUNE. Sept, 2001 to Sept, 2003.

Looking after Quality assurance of projects related to the air condition

design, security access and fire safety alarms using package EBI, XEBI,

EXBI (Honeywell controller controlling in house packages).

Projects completed :

1. Rio Hondo Schools

2. USA Newyork Sheretons Building.

3. ICICI Bank.

Languages used : VC++,VC+, VB, Java.

Education:

M.Tech (Process Design- Process Engg.) from I.I.T. Delhi in 1997.

B.E.MECHANICAL. (I class with Distn.) from M.I.T. Pune in 1995.

H.S.C. (I class) from J M Rathi English School, Roha in 1991,

MUMBAI Board.

S.S.C (I class) from J M Rathi English School, Roha in 1989,

MUMBAI Board.

PROFESSIONAL QUALIFICATION: Passed Diploma in Materials Management from

Wellingkars' Mgt. Institute, Mumbai.

SOFTWARE PROFICIENCY

OPERATING SYSTEM : WIN NT, WIN 98, XP.

LANGUAGES : C, C++, VC+, VB, JAVA

TOOLS : AutoCAD R 14, GUS, MS Project.

OTHER ACTIVITIES HANDLED

. Responsible for Project Budget Preparations.

. Participate and contribute in project planning and project execution

methodology.

. Develop project plan and schedules by using computer techniques.

. Assist in site selection and clearances, Monitor Procurement, Planning

and cost control activities for the projects.

. Arrange for know-how /basic engineering / detailed Engg. and other

services.

. Present monthly Progress and Cost Reports.

. Monitor day to day Site Project activities through Site / project

Engineers.

. Conduct price negotiations, bid analysis, Co-ordination for Purchase

Orders and Contracts.

. Expedite supplies and vendors engineering documentation.

. Coordinate with Engg. Group and resolving site problems.

. Certify contractors / vendor bills/ invoices and approve payments and

carry out and maintain vendors accounting.

. Monitor and Obtain Statutory Approvals, Liaison with local authorities

through Project engineers & Administration persons for Local approvals/

permissions.

. Ensure Mechanical & Electrical, HVAC, utility & other services

Completion.

. Coordinate with production departments for pre-commissioning /

commissioning activities.

. Formulate and maintain records of engineering documentation for new

facilities.

. Coordinate and assist in trouble shooting at sites while installation &

commissioning.

. Preparing and Monitoring Vendor / Contractor Data Bank.

. Monitor and regularize local purchases.

. Preparation of periodic Progress Reports.

. Feedback to planning on cost monitoring.

DATE: SHAILESH S. GOKHALE.

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