Project Engineer / Project Manager

ALBERT J. DAILY III

732-***-**** ▪ ************@*****.***

MANUFACTURING MANAGEMENT PROFILE

Detailed-oriented and integrity-driven professional with 17 years’ successful manufacturing experience within biotechnology and pharmaceutical industries. Consistently deliver strong and sustainable improvements to operations and productivity by developing skilled cross-functional teams, leading by example and ensuring compliance to government and industry regulations.

▪ Biotechnology ▪ Performance Improvement ▪ Quality Assurance/Control

▪ cGMP ▪ Pharmaceutical ▪ Regulatory Compliance

▪ Class 100 Cleanrooms ▪ Process Improvement ▪ Standard Operating Procedures

▪ Class 10,000 Cleanrooms ▪ Production Scheduling ▪ Team Building

▪ Class 100,000 Cleanrooms ▪ Project Management ▪ Training & People Development

PROFESSIONAL EXPERIENCE

IMCLONE SYSTEMS (Eli Lilly and Company Subsidiary), Branchburg, NJ, 2003–Present

Manufacturing Supervisor II – Purification, 2004–Present

Manufacturing Supervisor II – BioService Support, 2003–2004

Selected to serve as interim Manager and oversee two departments for nine month period during organizational transition period and directly involved with professional development and promotion of employees to management level positions.

 Manage Class 10,000 Purification and Buffer Preparation operations for Commercial Manufacturing department.

 Ensure employees are trained in Purification processes and operate in compliance with cGMP, Quality Assurance and safety standards by providing on-going training on Standard Operating Procedures (SOPs), batch record documentation and yearly cGMP requirements.

 Provide technical and operational process development for 10 direct reports along with assigning and reviewing work order requests.

 Decreased production batch records pages by 50%.

 Led major process related investigations and closed within allocated timeframes.

 Served as main liaison for several successful FDA/Team Biologics and Regulatory Agency inspections (EMEA. Canadian, Mexican and BMS).

 Authored numerous batch records, SOPs, and technical documents.

 Worked closely with Engineering, Facilities, Validation, Manufacturing Technology, Metrology, Logistics and Quality departments.

 Assisted in the implementation of StarLIMS, ELM (Electronic Learning Management), Pilgrim (Electronic SOPs and batch record system) and eTime (Electronic Time Management) initiatives to staff.

ORGANON INC., West Orange, NJ, 2000–2002

Sterile Production Supervisor/Associate Manager

Promoted from Supervisor to Associate Manager and hand-picked to help run department during Manager’s six month sick leave.

 Oversaw production of 40 Operators and worked closely with Consultants, Engineers and Quality Assurance staff on demolitions and clean builds.

 Increased production by 10% by streamlining process set-ups and reallocating staff.

 Managed Class 100, 10,000 and 100,000 Cleanroom production operations including liquid and lyophilized filling operations, parts preparation, compounding and production packaging operations.

 Conducted ongoing cGMP and SOPs training for 40 production personnel.

 Recognized for two successful FDA audit interactions.

ALBERT J. DAILY III, page 2

732-***-**** ▪ ************@*****.***

SMITHKLINE BEECHAM PHARMACEUTICAL, Piscataway, NJ, 1993–2000

Microbiologist, 1998–2000 & 1993–1995

Accelerated advancement (started as temporary employee) through a series of increasingly responsible positions within Aseptic Filling and Microbiology departments.

 Revised sampling plan for building’s main water treatment system.

 Monitored Class 100 Cleanroom environments.

 Performed product sterility testing via isolation technology, reading monitoring media, laboratory assays and water collection and testing.

 Trained production Operators on microbiology sampling and revised SOPs.

Sterile Production Filling Supervisor, 1995–1998

 Managed production operations for Class 100 Cleanroom powder filling and liquid filling areas, packing operations and all associated production batch records and deviation reports.

 Oversaw batch compounding, component and parts preparation operations in Class 10,000 Cleanrooms and monitored the water system.

 Implemented LIMS and batch record reduction implementation initiative and assisted with online operation of liquid filling.

 Prepared and updated SOPs requiring no additional revisions.

 Conducted monthly cGMP and first aid training for 16 union personnel.

COMPUTER SKILLS / MACHINARY

Microsoft Office Applications, LIMS/StarLIMS, eTime, ELM/Plateau, P-Trend, Documentum, SAP, Pilgrim, Trackwise, iFix, TrendServer Pro, B&S Fillers and Glass Washers, Gilowy Glass Washers, Perry Powder Fillers and Cozzoli Powder and Liquid Fillers, Edwards 240 & 280 Freeze Dryers, Millipore Chromatography Software/Skids, Amersham Chromatography Columns and Packing Stations, Millipore Tangential Flow Filtration Skids

AWARDS/ACHIEVEMENTS

ImClone Systems Extraordinary Effort Award (Top Achievement Award) – 2003 & 2005

ImClone System Appreciation Awards for Completing Assigned Tasks Ahead of Schedule, Preparation for Successful Audits, Exemplary Work on Cross-Functional Team Projects, Leading Successful Facility Restoration After Power Outage

PROFESSIONAL DEVELOPMENT/TRAINING

Frontline Leadership, Dale Carnegie Leadership Training for Managers, Leadership Development Initiative, Train the Trainer, How to Effectively Manage People, How to Motivate and Influence People, Coaching and Team Building Skills for Managers and Supervisors, Excelling as a Highly Effective Team Leader, How to Excel at Managing and Supervising People, Kepner-Tregoe (KT) Problem Solving and Decision-Making, Penn State Separation Purification Strategies for Biotechnology Products Training, GE Healthcare Bio-Services Column Packing Training, First Aid Training, Quality Systems Training

EDUCATION

Bachelor of Science in Biology, Tuskegee University, Tuskegee, AL - 1992

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