Supervisior

DIPAK NAIK

* ******* ******

CLIFTON, NJ *****-2929

Cell : (201) 294 - 8001

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

OBJECTIVE : Position with opportunities for career growth in pharmaceutical industry.

QUALIFICATIONS: Highly motivated young Supervisor/ Process Chemist/ Development Chemist

with more than 22 years of experience with particular skills achieved during

the experience.

. Teamwork . Result oriented work.

Professional Exposure:

. Work ethics include organized working as per procedures, meeting deadlines, and

responding and adapting to changes or urgencies.

. Knowledge of operating procedures of various equipment and data maintenance.

. Understanding of development criticalities and technical documents.

. Competent and believe in team work to accomplish tasks.

. Experienced with production equipments, batch records, process validation, and cleaning

procedures.

. Knowledge of safety standards pertaining to operations and equipment.

. Respect colleagues and superiors, follow instructions and carry out work in timely manner.

EXPERIENCE: Technician Bristol Myers Squibb New Jersey October, 2009 to Present

 Work with scientists for the development for new / modified formulations for solid oral dosage forms in product development department. Conducting process development to facilitate development of immediate release and controlled release / sustained release dosage forms.

 Support daily formulation and clinical manufacturing activities, such as dispensing, solution preparation for wet granulations and film coating and encapsulation operations, as per batch records. Perform experiments and record detailed information / observations regarding process of product in laboratory notebook. Worked on Scale-up / Clinical batches in manufacturing area.

 Provided vital input for troubleshooting and new ideas for process and product development.

 Perform set-up, troubleshoot, routine maintenance and repair of blending / granulation equipments, compression machines, multi purpose fluid bed dryer / coater / granulator and encapsulation equipments.

 Perform in-process and finished product sampling for physical, chemical and stability testing. Perform physical testing and document in laboratory notebook and batch records. Maintain all DEA and non-DEA inventory

 Follow written and oral instruction with limited supervision.

 Support daily laboratory activities prescribed by development scientists of said action.

R&D Associate Sunrise Pharmaceuticals New Jersey April, 2009 to October, 2009

R&D Associate Alpharma Pharmaceuticals New Jersey August, 2008 to March, 2009

 Work with scientists for the development for new / modified formulations for solid oral dosage forms in product development department. Support daily formulation and clinical manufacturing activities, such as dispensing, solution preparation coating, encapsulation operations, as per batch records. Perform experiments and record detailed information / observations regarding process of product in laboratory notebook.

 Provided vital input for troubleshooting and new ideas for process and product development..

 Perform set-up, troubleshoot and repair encapsulation, compression and multi purpose fluid bed dryer / coater / granulator.

 Perform and responsible for routine maintenance of encapsulation and compression machines Such as ELANCO model-8,GKF-1500,MG-2,CT-40, DC-16, BBC-35 and sejong.

 Perform and responsible for routine maintenance of coating machines such as multi purpose fluid bed dryer / coater / granulator, Accela-cota 48”-60”and compulab

 Perform in-process and finished product sampling for physical, chemical and stability testing. Perform physical testing and document in laboratory notebook and batch records. Maintain all DEA and non-DEA inventory.

 Generated master production record, process study protocol and SOP’s.

 Trained new technicians / machine operators, supervised their work, and provided guidance as required. Supervised Scale-up / Clinical batches in manufacturing area.

R&D Associate Sun pharmaceutical Industries, Inc. New Jersey January, 2006 to August, 2008

 Work with scientists for the development for new / modified formulations for oral solid dosage forms in product development department.

 Perform experiments and record detailed information / observations regarding process of product in laboratory notebook.

 Provided vital input for trouble shooting of mechanical, electrical and pneumatic process and new ideas for and product development.

 Generated master production record, process study protocol and SOP’s.

 Trained new technicians /operators, supervised their work, and provided guidance as required.

 Supervised Scale-up / Clinical batches in manufacturing area.

 Conduct process development to facilitate development of immediate release and controlled release / sustained release dosage forms.

 Participated in all activities such as market study samples, weighing of ingredients, granulation / blending, compression, film coating and sugar coating of tablets. Preparation of immediate release and sustained release seeds in product development department.

Process Chemist FMC Biopolymer New Jersey August 2005 to January 2006

 Responsible for test of new raw materials used for solids dosage forms, including ingredients for direct compression and aqueous film coating.

 Perform coating and compression trials in support of in-house and external projects.

 Perform wet granulation and spray drying / coating experiments.

 Conducted formulation scale-up and protocol validation.

 Prepared reports for all prescribed activities, collecting experimental data and observation.

 Follow written and oral instruction with limited supervision. Prioritize and plan internal and external experiments. Support daily laboratory activities prescribed by development scientists of said action.

Development Chemist CHR HANSEN INC. New Jersey January 1997 To July 2005

Responsible for development of Aqueous / Organic film coating formulation and coating techniques and complete project involving application for products.

Identified and conducted technical feasibility studies for new product concepts, line extension and new application techniques or areas for film coating and excipients. Performed customer laboratory technical service requests from conception to completion by developing high quality, commercially stable colors and film coatings, which resulted in sales. Handled film coating, color and excipient related technical inquiries and correspondence received from customers and account managers in support of Chr Hansen Inc. marketing effort.

Assisted in defining and establishing quality control techniques and procedure for the product line and performing necessary testing requirements. Developed and collected promotional literature, industry technical developments, from a technical point of view, in support of product lines.

Provided support for plant QA/QC with all necessary documentation and physical samples as well as travel to the manufacturing facility when necessary to assist in the transfer of product into manufacturing.

Supervised five technicians who operated various kinds of film coating equipment.

Pilot Plant SIDMAK LABORATORIES INC. New Jersey December 1985 To January 1997

Supervisor

Supervised operation and troubleshooting of manufacturing equipment/instruments for solid dose medicine involving following with quality control on products.

• Granulation/Compounding: Various types of blenders including Ribbon Blender, V-Blender, Gemcomatic and Jacketed Blender for granulation. Drying equipment such as Fluid bed dryer/coater and vens. Milling machines such as Fitzmill, Comill and Ball mill.

• Compression: Various kinds of tablet presses including DC-16, BBC-35, Kikusui- a computerized machine Killian and Sejong.

• Coating: Experience in use of Conventional Pan, Accela cota and Hi-coater. Formulation of Coating e.g. film coating, sugar coating, glaze coating and enteric coating. Specialized in operation and troubleshooting of capsule manufacturing machine e.g. Elanco, Rotofil, CT-40 and GKF-1500.

Participated in formulation of various ingredients for tablets, caplets, capsules and soft gels capsules. Prepared pre-clinical and clinical batches for ANDA and NDA submission. Technology transfer for scale-up and bio-batches with full report confirming FDA guidelines to regulatory department.

Computation of yield and preparation of daily reports.

Supervision of nine technicians operating various kinds of equipment/instruments in R&D.

Manufacturing Adarsh Chemical & Fertilizer Ltd., Surat, India. August. 1984 To July 1985

Plant Supervisor

Experience as a Plant-Supervisor. Supervision of Fifteen (15) operators operating various kinds

Of equipment/instruments.

EDUCATION: 3 years College Study (Major: Chemistry – Subsidiary: Physics).

PERSONAL: Energetically accept responsibility. Excellent practical/technical skills.

REFERENCES: Available upon request.

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