Michelle Monk Email & Phone Number

Denver, Co, Us

Louisville, Co

Work as a program manager to provide technical leadership for advancing the Hyde Laboratory capabilities, manage projects to support cleaning validation, and consult with clients to develop and improve cleaning programs.• Oversee laboratory studies in the areas of cleanability, degradation, TOC, visual residue assessment, and extraneous matter to ensure project milestones are met.• Perform carryover calculations and assessments to provide appropriate recommendations to mitigate risk.• Provide thorough guidance and recommendations for cleaning validation programs by preparing documentation such as master plans, SOPs, validation protocols, and reports.• Perform cleaning risk assessments to identify the severity of carryover, likelihood of occurrence, and probability of detection.• Support the development of new cleaning programs. • Support client training programs, such as swab and visual inspection qualifications.• Aid in developing new lab-scale methods to support full-scale cleaning activities, such as rouge removal and passive layer resistance studies.

Longmont, Co

Worked as a lead engineer within the Process Development Department to characterize the cleanability of drug substance and drug product soils. Led to significant cost savings by successfully enabling completion of new product introductions, streamlining strategies for cleaning validation, and developing robust cleaning cycles.• Managed the laboratory to direct work and meet timelines by mitigating risk.• Promoted efficient work in the laboratory by performing instrument maintenance and qualifications, managing sample chain of custody and inventory, and improving procedures.• Orchestrated multiple global projects to gather information and troubleshoot issues.• Designed experiments and analyzed data to make cost-effective and time-saving recommendations for cleaning validation and cleaning cycles.• Supervised multiple global workstreams to implement and ensure adherence to regulatory agency expectations. Resolved critical compliance risks for material control, sample handling and chain of custody, and equipment management.• Oversaw laboratory and department safety and coordinated with EHS to prevent safety incidents.• Strategically evaluated and optimized processes and cleaning cycles to reduce cost, decrease failures, and increase efficiency.• Led and managed cleaning characterization studies that simplified cleaning validation activities and provided up to $500,000 of cost avoidance per project.• Facilitated and engineered the fabrication of a full-scale equipment modification, resulting in more robust cleaning evaluations.• Assisted in the design and creation of a new small-scale cleanability apparatus, which simulated a falling film inside a vessel and ensured more compliant cleaning characterization evaluations. • Led the implementation of 5s lean principles in the laboratory to increase efficiency and eliminate redundancies.

Boulder, Co

Worked in the Analytical Chemistry Department to confirm the quality of products and processes, which enabled Amgen to provide for patients, adhere to regulatory expectations, and meet timelines. • Supervised all laboratory work and made management level decisions to ensure quality work during shift.• Led several TOC recovery projects, including a unique study which allowed Amgen to meet a production timeline that would otherwise be delayed. • Coordinated several analytical method transfers and validations, resulting in compliant validations. Included a unique method that required assessing testing parameters and designing testing processes without the use of a template.• Trained and mentored new staff members on laboratory procedures and analytical methods to deliver consistent work and enhance the team environment. • Followed environmental, safety, GLP, and cGMP/CFR guidelines to maintain compliance requirements. • Frequently wrote validation protocols, analytical methods, and technical reports, generating comprehensive documents to increase productivity.• Analytical skills: UV/Vis, HPLC, TOC, endotoxin (LAL), pH, conductivity

Ames, Ia

Worked in the Water Quality Group to prepare solutions and ensure quality, meeting production timelines and providing clients with quality test kits and reagents.• Performed QC tests on products to maintain requirements of Hach’s Quality Management System, which was based on the ISO 9000/Q9000 Series Quality System Standards.• Independently prepared chemical solutions to meet demands of retail distribution. Met critical deadlines, including same-day deliveries. • Established weekly plans to coordinate production and shipping schedules. • Collaborated with cross-functional teams to assist with workloads due to completion of individual work ahead of schedule.• Analytical skills: BOD, titrations, pH, conductivity