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JOSEPH JOBSEEKER
7777 Great Job Drive                                                                                                                       
Happyland, CA  90000
555-55-5555
joe.jobseeker@yahoo.com

SUMMARY
              
Accomplished, results-oriented Pharmaceutical/Quality Professional, technical manager, ASQ Six Sigma Green Belt and Quality Improvement Associate, with extensive industry experience, domestic and international, in the areas of Technical Transfer, Technical Services,  Quality Assurance, Manufacturing, Packaging, Research and Development, Engineering, Operations Training, Bioresearch/Toxicology.  Demonstrated and recognized reputation as an energetic, motivated, creative self-starter with strong leadership skills and ability to build, develop, and lead superior work and technical teams focused on excellence. Possess excellent technical, observation, investigative, and interpersonal skills. Key strengths and core competencies include:

PROFESSIONAL HISTORY

SUPER PHARMACEUTICALS, Watson, RI                                                                                        2009 - present
Specialty pharmaceutical company focused on niche categories including controlled substances and technically challenging products.

Technical Services/Technology Transfer Specialist – Technical Services (Watson, RI manufacturing site)
Technical specialist responsible for the technical transfer, scale-up,  process validation and launch of new products at contract manufacturing sites.

• Oversee execution of new product technology transfer projects at contract manufacturing sites.
• Organize project teams, define milestones, support gap analysis and assist with scale -up, qualification and validation activities.
• Develop and  lead technical teams to prepare for new product launches
• Provide technical support to the contract manufacturing site to ensure that commercial manufacturing processes are robust and capable of producing to specification.
• Author Manufacturing Validation Protocols, Batch Records, Technical Reports and SOPs.
• Drafted company's first Technology Transfer SOP/guidance document.

ADVANCED PHARMACEUTICALS INC., Nashville, AR                                                                      2006 - 2009
A leading specialty pharmaceutical company that develops, manufactures, markets and distributes brand and generic pharmaceutical products

Manager –Manufacturing Support, Engineering
Specialized Senior Technical Manager providing compliance leadership, subject matter expertise and support to Technical Services, Manufacturing, Packaging, R/D, Validation, Quality Assurance, Environmental Health & Safety, Operations Training, Pharmacy, and Set-up.

• Re-wrote company cGMP gowning policy. Trained all operations personnel at Florida sites.

       SOP revision is considered to have the most immediate compliance impact in recent company history.

• Led a collaborative team effort that reduced fluid bed manufacturing delays and interruptions by 67%.
• Initiated manufacturing delay reduction program that provided 80 tools kits to operations personnel resulting in a reduction of general equipment set up/tear down times by 1.25 hours.
• Implemented and trained operations personnel on use of “clean parts cart” for Kikusui and Fette tablet presses  resulting in 25-33% lost time improvement by reducing lost parts search time. 
•  Led Hazardous Analysis Team creation and implementation of first company Confined Space Entry program.

GREAT PHARMACEUTICALS, Bismark ND                                                                               1985 - 2006
Excel is a global leader in pharmaceuticals, consumer and animal health care products.

Manager – Quality Operations, Incoming Inspection and Sampling Unit (2004 - 2006)
Sr. Manager responsible for directing  all unit operations involving the planning, scheduling, sampling, inspection, testing, release for over 3000 Rx/OTC packaging components and raw materials, and bulk chemical deliveries while ensuring safety, compliance with policies/Conformance Standards and SOP's. Liaison for FDA and Foreign Government inspectors.  Supervised thirteen self-directed inspection analysts.

• Improved the monthly delivery rate of components and raw materials to the Production floor from 95 to 100% through collaborative and reprioritization efforts with Purchasing and Warehouse personnel.
• Implemented a 5-S (Sort, Straighten, Shine, Standardize, Shine) /Visual program for the department.
• Directed purchase and qualification of Interga 9500 barcode reader. All qualifications activities completed within 90 days of installation.

Process Project Engineer – Technical Services (1995 - 2004)
Team Leader, technical Subject Matter Expert,  with primary responsibilities for managing film coating operation of EffexorÒ ($3.4 B annual sales) and InderalÒ in three Glatt GPCG-60 fluid bed processors while providing 24-hour technical support and troubleshooting for plant operations.  Supervised one senior and four junior Process Engineers.

• Led initiative and was responsible for implementing high speed film coating process in the GPCG-60 fluid bed processor decreasing spheroid coating time from 5 to 2.8 hours, and reduced rejects saving by over $800,000 annually.  Process developed was adopted and implemented at Excel’s New Bridge, Ireland facility.
• Successfully directed a highly motivated, six person technology transfer team for Effexor® High-Speed Spray Rate transfer to Guayama, Puerto Rico facility.  Effort reduced overall transfer time by 4 months.
• Led Process Analytical Technology (PAT) evaluation for use of tunable diode laser absorption spectroscopy method and instrumentation to measure gas phase concentrations of solvents in the fluid bed processors.
• Reduced unnecessary or duplicate EffexorÒ granulation Batch Record entries by 46% through an in depth process review.
• Executed technology transfer, scale up and validation of three product lines into Appleville facility. All transfers were completed two months ahead of schedule.

Process Engineer– Process Research and Development, Scale-up Division (1991-1995)
Technical transfer Team Leader for new product formulation to include new and existing equipment modifications.  Supervised two junior Process Engineers.

• Performed international site and process validation for the extraction of estrogens from Pregnant Mare’s Urine (PMU) into a pharmaceutically active compound.
• Executed the manufacturing and tabulating validation process and technology transfer of four ultra low dose oral contraceptives to Puerto Rico.
• Master Sampler: Demonstrated ability to achieve consistent analytical results when using a variety of sample thief designs.
• Manufacturing Investigation Report Team member responsible for design of current organization structure.

BEST PHARMACEUTICAL, Bismark ND                                                                              1985 - 1991
Service Supervisor – Quality Assurance, Incoming Inspection and Sampling / Assistant – Quality Assurance Record Review / Systems Auditor – Quality Control/Product Compliance / Necropsy Technologist – Pathology Department/Animal Research Division

Prior Professional Experience

Pharma Research Laboratories, Visit, NH
Elway Bioresearch, Mammoth, CA

EDUCATION and CERTIFICATIONS

University of California, Riverside - Bachelor of Science (BS); Animal Science
Six Sigma Green Belt
Quality Improvement Associate
cGMP Trainer
 Laboratory Animal Technologist

AWARDS

• President’s Achieving Excellence Award
• Managing Directors Special Recognition Award for Outstanding Contributions
• Technical Transfer Team (Western SC/San Juan PR) - Best Practice Award
• Technical Transfer Core Team - Achievements and outstanding Contributions
• Process optimization - Valuable contributions
• High Speed Spray Rate Team  - Outstanding demonstration of company values