Pharmaceutical manufacturing professional with over 24 years of experience. Strong technical skills in all phases of pharmaceutical manufacturing, specializing in difficult to manufacture extended release products. Career history of building, motivating, and leading teams. Proven track record of maximizing resource utilization, streamlining operations and costs while increasing profit and customer service levels. A leader of continuous improvement,
Pharmaceutical manufacturing professional with over 24 years of experience. Strong technical skills in all phases of pharmaceutical manufacturing, specializing in difficult to manufacture extended release products. Career history of building, motivating, and leading teams. Proven track record of maximizing resource utilization, streamlining operations and costs while increasing profit and customer service levels. A leader of continuous improvement, utilizing Operational Excellence and Continuous Innovation programs with successful results. Excellent overall communication skills.
Manufacturing Manager @ Responsible for managing a highly-technical, fast paced, manufacturing department with more than 200 employees on a 5 shift operation. Responsible for employee safety, training and development. Support the site in implementing safety guidelines for manufacturing, which includes sponsoring/participating in safety teams and improvement initiatives. Responsibilities also include managing the department budget and controlling cost. Ensure compliance to demanding standards of external regulatory agencies including FDA, European agencies, DEA, OSHA, and associated inspections. Complete Quality Investigation Reports (QIR’s) as required through data collection and analysis in a timely manner. Initiate CAPA’s as required and measure effectiveness to ensure improvement is sustained. Member of the Operational Excellence team, supporting productivity improvement, quality, and cost- saving projects throughout the site. Schedule work centers and ensure that manufacturing metrics are attained. Maintain area documentation (Revise / Initiate WFP's and SOP's utilizing the change control process). Purchase and implement manufacturing equipment and maintain operating supplies. *Accomplishments Supported implementation of JDE system and DSI portable scanners in order to track/record labor hours/inventory. Cross-trained operators in order to support all manufacturing operations. Supported IQ/OQ of new manufacturing equipment. Transferred products between buildings/sites in order to continue manufacturing and meet customer commitments. Revised and implemented supporting SOP's and batch records. Supported several inventory building initiatives for new product launches as well as inventory increases of current products per customer demands. Supported manufacturing in increasing output from < 100mil to >200mil SDU's/month. Successfully doubled output of the sites highest volume product through effective equipment utilization and personnel training. From July 2004 to Present (10 years 9 months) Ft. Lauderdale FlManufacturing Supervisor @ Supervised chemical and syrup manufacturing, granulation, blending, fluid bed operations and pharmacy areas. Ensured compliance to demanding standards of external regulatory agencies including FDA, DEA and OSHA. Scheduled work centers, and ensured that manufacturing metrics were attained. Responsible for employee training (GMP's, SOP's and WFP's). Maintained area documentation (revised / initiated WFP's and SOP's). Completed quality investigation reports (QIR's) and deviation notices as required through data collection and analysis. Purchased and implemented manufacturing equipment and supplies. Operated within department budgetary guidelines. *Accomplishments Maintained First Past Quality metrics above 95% consistently. Supported manufacturing in successfully launching over 18 new products. Maintained a successful on time delivery of a $1.2 billion product line for 32 straight months. Facilitated successful product transfers to Puerto Rico, assisting in technology transfer through validation and commercial batches. Supported site capacity expansion projects (scale-ups) on Colette Gral High Shear Granulation, and Niro Fluid Bed Dryer. Supported the implementation of RWEIGH (Ropics Weigh), for weighing, checking and charging raw materials. Acquired responsibility of bulk chemical manufacturing department and successfully updated area in accordance with cGMP'S and OSHA in order to fulfill contract requirements for manufacturing bulk chemical API. From September 1990 to March 2004 (13 years 7 months) Greater New York City Area
BS, Business Management @ University of Phoenix From 2007 to 2010 Joseph Halleran is skilled in: Sop, GMP, Pharmaceutical Industry, Manufacturing, Operational Excellence, Continuous Improvement, FDA, Validation, Change Control, Trackwise, Quality System, CAPA, Computer System..., V&V, 21 CFR Part 11, Quality Assurance, Cleaning Validation, Regulatory Affairs, Technology Transfer, Biopharmaceuticals, ISO 13485, Cross-functional Team..., Quality Auditing, SOP development, Quality Control, Software Documentation, Pharmaceutics, GxP, GLP, LIMS, Contract Manufacturing, Aseptic Processing, TrackWise, Root Cause Analysis, Lean Manufacturing, Process Improvement, SOP, Management, Leadership
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