Darrell Lowman Email & Phone Number

• Responsible for Site Quality Assurance.• Development, establishment and implementation of the quality management system, which support the requirements of 21 CFR 210 / 211 for drugs and 21 CFR 820 for medical devices.• Management Representative.• Manage and monitor the overall training program.• Manage and monitor the change control process and promotional material review process.• Responsible for overall site safety.• Manage, monitor and trend Supplier Management and Approved Supplier List (ASL), Corrective and Preventive Action Program, Non-Conforming Material Process, Deviation Process, and Rework / Reprocess / Repair / Salvage Program.• Responsible for shipping, receiving and inventory control.• Responsible for the review and release of finished drug products and medical devices at the Approved Distributor of Record.• Responsible for recall process to ensure traceability of the finished drug product and medical device.• Responsible as the designated representative for state distribution / virtual manufacturing licenses.

• Assisted in the successful PAI Inspections of the Drug Manufacturing Area and the Device Manufacturing Area with no 483’s.• Assisted in ten consecutive (drug and medical device) FDA Inspections with no 483’s issued.• Support ISO Certification effort to maintain QSR, GMP, ISO13485, MDD, CMDR and other applicable regulatory compliance requirements and internal regulatory activities. • Setup quality inspection and quality procedures when drug and device manufacturing/service was brought in-house to include: Standard Operating Procedures (SOPs), product testing, finished product specifications, and processing records.• Responsible for the batch record review and approval; evaluation and approval of executed production records, and approval for final product release.• Supplier Management through controlled selection and certification of suppliers and laboratories with the emphasis on the pharmaceutical supplier base. • Investigate non-conforming materials and deviations for root cause analysis, audit drug manufacturer's process and quality systems to ensure compliance and adequacy, audit drug testing laboratory to ensure compliance and adequacy. • Investigate complaints, field returns and concerns, perform complaint analysis and failure investigation; monitors and reports on return trending and efficacy of corrective actions relating to Adverse Drug events and all other drug related complaints. • Supports new product development and implementation via development of an overall quality plan, including needed inspection, test, and audit procedures. Support of process/product validation. Design of experiments to identify and thus control process variables. • Responsible for the updating of the CMC section for the IND, and NDA Annual Reports/Supplements. • Responsible for the site transfer of methods and stability without interruption in supply of product.• Manage, monitor and trend the Stability Program.

• Ensure compliance with CGMP, 21 CFR 210/211, Standard Operating Procedures (SOPs), product testing, finished product specifications, and processing records.• Establish procedures, test methods, and specifications as necessary to maintain a quality system.• Approve division SOPs. • Perform internal audits to ensure that all departments are training personnel appropriately.• Direct and approve all quality assurance investigations, laboratory out of specification investigations (OOS), incident reports and batch failure reports.• Responsible for customer complaints system and analysis of trends.• Manage the change control system for the division.• Direct the execution of all validation protocols for the division.

• Responsible for interacting with the Food and Drug Administration for chemistry related inspections and response.• Ensure all laboratory personnel follow CGMP, Specification and Procedures used for Product Testing, and all Company SOPs in the Ophthalmics Division, Cough and Cold Division, and Personal Care Division. • Ensure that all manufacturing processes are properly validated, and assist in the planning of new procedures for any new manufacturing process.• Ensure that all laboratory personnel are trained on the operation, maintenance, and calibration of all laboratory equipment. • Write, review, and update division and corporate SOPs as needed. • Develop and validate analytical methods for new products in the Ophthalmics Division (Generic Prescription and Over the Counter Ophthalmic Solutions), Cough and Cold Division (Generic and Contract Manufactured Cough Drops, Throat Drops and Throat Lozenges), and Personal Care Division (Generic Douche, Enema, Pediatric Oral Maintenance Solution, and Eyewash) utilizing the HPLC and GC.• Participant in Planning Meetings to interface with Contract Customers such as: American Home Products, Warner Lambert, Warner Lambert Canada.

• Ensure that all aseptic manufacturing processes are properly validated, and assist in the planning of new procedures for any new manufacturing process.• Supervise the development and validation of all new methods.• Ensure that all old methods are fully validated and meet the current USP requirements. • Prepare new batching paperwork for all new products. • Perform cleaning validation and develop methods for determining residual on the surface of equipment utilizing CE, HPLC, GC, and TOC.

• Responsible for assisting the LANES Team Leader in the planning, development, coordination and execution of LANES exercises. • Planned and conducted training on Army Common Soldier Leader and collective tasks to be exercised during LANES training with training units in accordance with established Army Lanes training doctrine.

• Responsible for the planning, conducting, management and evaluation of all unit training. • Prepared and coordinated the unit’s Yearly Training Calendar, Monthly Training Schedules and the Annual Training Schedule consistent with the Yearly Training Calendar. • Maintained all documentation of training conducted during the training year and monitors MOS training and career development of unit members. • Maintained and updated the unit Alert Roster and Family Support Rosters.

• Supervised four (4) Analytical Bench Chemists and one (1) Method Validation/R&D Chemist on a daily basis in the quality control chemistry laboratory. • Ensured all laboratory personnel follow CGMP, Specification and Procedures (Spec & Pro) used for Product Testing, and all Company SOPs. • Assigned duties, monitor the progress of work and review all completed work in the laboratory notebooks. • Performed USP/NF Monograph Assays and internal SOPs to release raw materials, bulk product, finished product and test stability product. • Managed the stability program and ensure that all closure systems are placed into stability and tested as per the stability program protocol.• Modernized the chemistry laboratory with new TSP HPLC, TSP CE, HP GC with FID, TCD, and Headspace Analyzer, HP Diode Array Spectrometer.

• Commander of a 155mm self propelled Field Artillery Battery. • Assured that the battery was properly trained and prepared to mobilize in support of the 3/42 Field Artillery. • Responsible for the overall maintenance of the battery.• Ensured that safe, accurate, and timely artillery fires were ‘On Time - On Target’. • Ensured that the battery is layed and safe within the battalion standard. • Trained the eight gun sections, FDC, and maintenance sections for timely occupations and displacement. • Ensured that all command directive training objectives were met.

• Executive Officer of a 155mm (SP) Field Artillery Battery. • Specific tactical responsibilities to verify the lay of the battery, measure, and report piece direction, determine minimum quadrant elevation.• Ensured that bore sighting was accomplished as often as possible.• Ensured that timely and accurate fires are delivered by all cannon sections.• Ensured that before, during, and after operation maintenance is performed as required by technical manuals and operating procedures. • Ensured that inter-battery communications were maintained.• Ensured safe practices are observed to include proper fire commands, safe fire data and proper ammunition handling and storage.

• Performed HPLC and wet chemistry assays. • Performed training of laboratory personnel on USP/NF Monographs, and internal SOPs. • Ensured that all procedures are update when new supplements are received for the United States Pharmacopoeia.• Ensured that all laboratory personnel are trained on the operation, maintenance, and calibration of all laboratory equipment. • Wrote, reviewed, and updated company SOPs as needed. • Formulated and prepared laboratory batches for new product development.

• Served as Executive Officer/Counterfire Officer of a Forward deployed Target Acquisition Battery in Europe.• Compiled and submitted the Unit Status Report, CSS Slides, Project Partnership reports and Unit History.• Coordinated Morale Support activities.• Responsible for coordinating the processing and dissemination of counterfire intelligence and target information for the Division Artillery and Corps Artillery Brigades. • Class III Property Book Officer, accounting for all petroleum products in the unit.• Responsible for ensuring all command directed training objectives were met. • Responsible for the training, appearance, morale and welfare of my personnel. • Responsible for one AN/TPS-58, three AN-TPQ-36 and two AN/TPQ-37 radar sections and that the proper maintenance and care was taken with these high dollar pieces of equipment.

• Assisted the Battery Commander in the performance of his duties to include compiling and briefing data for unit status reporting. • Monitors the units Class II, IV and IX TUEMUS expenditures.• Class V PBO for Training Ammunition and UBL Ammunition.• Moral Support Fund Custodian, Deputy Test Site Manager, Arms Room Officer, Class A Agent and scheduling Class A Agents for the battery.

Course Graduate, Quartermaster Officer Advance Course Phase 1

Course Graduate, Defense Hazardous Materials/Waste Handling Course

Course Graduate, Transportation Officer Advanced Course Phase 1

Course Graduate, Observer Controller Course

Course Graduate, Combined Arms And Services Staff School (Cas3) Idt Phase Iib

Course Graduate, Combined Arms And Services Staff School (Cas3) Idt Phase Iia

Course Graduate, Field Artillery Officer Advanced Course Phase Ii

Course Graduate, Field Artillery Officer Advanced Course Phase I

Course Graduate, Combined Arms And Services Staff School (Cas3) Phase I Correspondence

Course Graduate, Field Artillery Target Acquisition And Survey Officer'S Course

Couse Graduate, Field Artillery Officer'S Basic Course

Bs, Biochemistry

Hs, Academic