Daniel Howley Email & Phone Number

Longmont, Colorado

Broomfield, Co

• Review documents and approve batch records on daily basis (three per day)• Hire, complete performance reviews, promote, and terminate employees in a group of 8-10 Small Batch technicians• Manage monthly in-house Quality inspections as well as unannounced annual FDA visits as the key representative from Small Batch Facility• Schedule operator assignments and processes in Small Batch• Ensure all manufacturing equipment is maintained and ready for use• Conduct periodic reviews of procedures (five documents per quarter)• Coordinate scheduling of preventive maintenance activities, microbiological testing, and cleaning validation tasks to not interfere with on-going work• Maintain appropriate Deionized (DI) Water status and cleaning schedule• Submit transaction order to raw material warehouse to order material via SAP (2-3 times per week)• Conduct and write department Deviations (monthly)• Own responsibility for Building Management System (BMS) in area; respond to processing room alarms via BMS system and generate work orders to resolve facility or room issues• Ensure visitors and contractors are trained in cGMP gowning requirements

Broomfield, Co

Broomfield, Co

• Tested numerous products (for tablet disintegration, bulk/tapped density, angle of repose, tablet friability and weight/hardness/thickness) to assist project scientists in determining product recipe, specifications, and manufacturing process• Manufactured four batches per week of 50+ products including notebook batches, confirming notebook batches, ANDA batches• Proactively communicated with management and project scientists on progress updates for new products and R&D activities

Broomfield, Co

• Managed team of 12-16 granulation technicians, including activities related to hiring, completing performance reviews, promotions, and terminations• Managed budget, negotiated with vendors, identified new sources for materials and ingredients, and generated Capital Appropriation Requests (CAR) • Scheduled operator assignments and processes in Granulation department• Performed all pharmaceutical granulation activities, including dispensing raw materials, wet granulation, milling, blending, unit blend sampling, tableting, encapsulation, Glatt Fluid Bed process, Laser Drill and some limited tablet coating processes • Manufactured five batches per week of two or three different product families • Ensured a compliant work environment through full adherence to cGMP practices• Conducted monthly department Safety and SOP training• Gave department tours to VIPs and government agencies (FDA, DEA, & OSHA)

Broomfield, Co

Suffern, Ny

• Managed materials for Packaging department / packaged pharmaceutical products• Manufactured pharmaceutical products in Therapeutic Transdermal Systems• Performed dispensing, mixing, milling, blending, and granulation tasks in Granulation Department

Mahwah, Nj

• Delivered mail, correspondence, and parcels• Set up book displays

• Performed all law enforcement responsibilities on base including crime investigations, traffic control, maintaining law and order, responding to domestic issues, and arresting suspects• Assigned to Altus Air Force Base (Oklahoma) and Ramstein Air Force Base (West Germany)

Coursework In General Studies And Police Science & Management

Coursework In General Studies And Business Management