MAHESH A. PATEL

** ******* **** • Parsippany, NJ 07054

Home: 973-***-**** • Mobile: 862-***-****

• E-mail: ac2hcq@r.postjobfree.com

OBJECTIVE & EDUCATION

To obtain an Analytical Chemistry Supervisor/Team (group) Leader position with a growing pharmaceutical company offering room for advancement and challenging applications in area of Quality Control/Analytical R& D.

M.S. in Organic Chemistry (1980)

B.S. in Chemistry (1978)

SUMMARY OF QUALIFICATION/SKILLS

Over 30 years of experience in the analysis of qualitative and quantitative of Pharmaceutical/Consumer Health Care products, technical support, and laboratory controls.

Good analytical skills in wet and instrumental analysis including strong problem solving with in-depth knowledge of instruments techniques/trouble shooting, such as HPLC, GC, Head Space GC, FTIR, ATR, KF, AA, UV/Vis, TLC, TOC analyzer, pH meter, Viscometers (mechanical & glass capillary types), Refract-meter, Osmo-meter, Particle size Analyzer, Elemental Analyzer, and Dissolution System., etc.

Good working knowledge with USP/NF, FCC, BP, EP, JP, ASTM, EPA, AOSC and departmental Specifications/Standard Operating Procedures (SOPs).

An excellent knowledge of ISO, cGMPs, GLP and Code of Federal Regulations regarding Health Care and pharmaceutical products in a highly regulated corporate environment.

Good computer skills proficient in the use of LIMS, SQ-LIMS, GIS, MAPS, AS400, PDOCS, Total Chrom, ACT, Calibration Manager, etc., and various other laboratory application systems. Hands on experience of word processors, excel, database software, and reporting tools.

Strong commitment to laboratory safety procedures and SDSs. Good knowledge of EHS and OSHA regulations.

Proven ability to handle multitasks in a highly stressful environment and results-oriented leader.

Exceptional interpersonal skills: proactive, personable, flexible, and team-oriented. Good reputation of establishing positive relationships with colleagues, customers, QA, sales, accounting, and HR departments.

Good organizational and time management skills.

PROFESSIONAL WORK EXPERIENCE

Gibraltar Laboratories, Inc – Fairfield Rd, Fairfield NJ-07004 05/2009 – Present

Chemistry Lab Manager - Primary Responsibilities

Competence in area to be supervised with 20--21 years of technical experience in raw materials, stability products, finished products and cleaning verification.

Organizing and monitor laboratory workload, re-prioritize as needed to keep work flow moving, and ensure completion of all tasks to meets turnaround time. Assure adherence of acceptable ISO 17025, FDA and cGMP/GLP practices by the staff during execution of all work tasks. Serve as a technical expert on the methods performed in the group and the results obtained.

Managed laboratory work for bench 6 -8 chemists and all group activities. Trained and mentored on daily activities.

Performed general chemistry lab tasks as well as wet chemistry techniques. Performed bench analysis on both the instrumentation and wet analysis as need to meets turnaround time.

Review test results for conformance within specifications and effectively document the results.

Responsible for responding to internal and external audits as well as deviation management, Investigation Reports as necessary. Ensured 100% of generated chromatograms are inspected and verified consistency of drawn baseline, integration parameters, and regression results of injected sequences.

Write, review, modified as needed and execute method development, method transfer, method validation and method verification protocols.

Write/review/modify SOPs/reports, General Protocols, EPA, GLP protocols and Stability protocols at various conditions including forced degradation study.

Evaluate data to detect product or method-related trends. Prepare SPC charts/graphs.

Use scientific expertise to provide assistance to Chemistry Staff with troubleshooting, laboratory investigations, CAPA and problem resolution.

Work closely with clients and other internal departments to ensure communication of critical information upward with higher management for key decision-making.

Worked as a Study Director and responsible for all aspects of the successful execution of projects from study startup to final report including protocol preparation, editing/review as needed, sample tracking, staff assignments and training including designing their experiments and following through on the execution of those experiments, scheduling resources, conducting studies in a cGMP/GLP environment, quality control, data review, and the drafting and editing of the final study report. Resolve technical difficulties and documentation issues that occur during the course of studies to

ensure timelines do not slip and that studies remain GLP compliant.

Performed troubleshooting of assays, impurities/ related substances or residual solvents on chromatography (HPLC, GC & AA), other instrumental and Wet chemistry analysis. Discussed the technical and scientific aspects of the study with the client. Proven track record in developing, growing, and maintaining client relationships through communication and consistently meeting critical client timelines. Corresponded with Sponsors on a daily basis.

Represent the company either regular or unexpected audits, through effective interactions including lab tours with Clients, A2LA, FDA, Safety and other Regulatory Agency officials, data review and discussion, close out meetings, and audit responses as needed related.

Ordered supplies as needed to complete projects on timely manner with consideration of departmental cost improvement goal.

Participate in the budget process. Monitor group spending to remain on track with budget. Worked to meet revenue targets. Assisted with Chemistry department forecasting.

Take initiative to make things better for the company through an assertive and aggressive approach. Collaborate new relationships by leading by example.

Evaluate, coach, and manage personnel performance. Set group objectives with management.

Identify analytical projects required to achieve group and company’s business objectives.

Plan and coordinate implementation of desired outcomes.

Johnson & Johnson – McNeil PPC Div

ision, Parsippany NJ – 07054 12/2006 – 03/2008

Acquired Consumer Health Care business from PFIZER INC in 12/2006

Pfizer Inc. - PGM Division, Parsippany, NJ -07054 12/1988 – 12/2006

Analytical Chemist/Team Leader – Primary Responsibilities

Performed routine and non-routine wet chemical and instrumental analysis on active and non-active raw materials, in-process samples, finished products, complaint samples, and stability samples (at correct stability condition) within the framework of cGMP and FDA guidelines. In a consistent and timely manner, documented and maintained cGMPs and FDA related activities in legible manner following established formats, specifications, and test procedures.

Experience with usage of instruments such as UV/Vis, IR and Atomic Absorption Spectrophotometers, as well as techniques including Thin Layer Chromatography, Dissolution Testing for Sustained Release, and Delayed Release tablets / gels.

Analyzed and determined Assay for potency, Content Uniformity Dosage, Purity, Impurity, Residual Organic Solvents, etc., of variety of raw materials/finished products/stability samples following Chromatographic techniques as per USP/NFFCC, BP, EP, compendia and established test methods.

HPLC- both the normal and reverse phase using various columns by isocratic and gradient elution

GC and Head Space GC- FID and TCD detection using packed and capillary columns by isothermal and temperature programmed.

Determined moisture contents by KF titrations and loss on drying.

Extracted samples by means of wet methods such as Acid value, Iodine Value, Hydroxyl Value, SAP Value, Ester Value etc.

Hands on experience in use of other laboratory equipments such as Osmometer, Digital density meter, pH meter, Conductivity meter, TOC analyzer, AA, Viscometers (LVT & RVT), muffle furnace, and Disintegration Apparatus.

Tested water samples for TOC and Conductivity by USP methodologies.

Analyzed trace metals of bulk drug substances by means of AA.

Prepared and maintained Indicator solutions, Test solutions, and Standardized Volumetric Solutions.

Participated, prepared, and reviewed Analytical Laboratory OOS investigation reports by Method-I.

Reviewed test data, LIMS worksheets, SQ-LIMS reports, data notebooks and validated in LIMS or SQ-LIMS. Released Raw Materials, finished products and Stability samples in MAPS by effective communication with production department and maintained high productivity.

Performed other duties in a safe and efficient manner as assigned:

Inspected, Reviewed and evaluated of Consumer Returned Complaint samples and Legal investigation of Complaints samples. Closed out timely manner and maintained database.

Served on a laboratory inspection committee and assisted management during regulatory inspection, e.g. safety, instrumentation & equipment, GMP, SOP, FDA and internal CQA (Corporate Quality Audit).

Participated Non-routine assignments such as transfer of technology, process validations, methods revision, specification revision, revision of SOPs associated with laboratory activities etc. Executed crossover of newly developed test methods against established methods for validation studies.

Assisted and provided training of new entry level analysts in various procedures of EHS, cGMP and SOPs. Provided proper directions in instrument troubleshooting and contributed in their on-going continuous improvement and developments.

Monitored, maintained and ordered as required inventories of Lab supplies, chemical regents, organic solvents, USP/EP primary Reference Standards, and in-house reference standards.

Coordinated, monitored and scheduled routine maintenance & calibration of Laboratory equipments to ensure compliance with cGMP. Reviewed and approved calibration reports, maintained in database.

Worked on special project of Annual Record Review of all retain products. Recorded of appearance change or degradation of the products. Planned and developed written proposal for Product Specification change.

PRIOR EXPRIENCES:

Quality Control Chemist – Gained additional QC Laboratory experiences by performing in by performing in Position of QC Chemist in various Pharmaceutical and Chemical companies

Private Formulation Inc. Edison, NJ 08817 09/1988 - 12/1988

Sidmake Laboratories Inc. East Hanover, NJ 07936 10/1988 - 09/1988

Par Pharmaceutical Inc. Spring Valley, NY 10977 07/1986 - 10/1986

Dipee Chemicals. Ankleshvar, India 07/1982 - 01/1986

ACCOMPLISHMENT/AWARDS:

(1)Pfizer Inc: For dedication and achievement of Parsippany PGM Quality Operations Raw Material Lab goals.

(2)Pfizer Inc: For negotiation and saving significant amount of money on price of Lab Supplies and achievement of Parsippany PGM Quality Operation Labs cost improvement goals.

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