Michael Ledesma Email & Phone Number

Bothell, WA, US

Bothell, Washington, US

-Served as subject matter expert, scribe, and request manager during the 2022 North Creek PLI activities which resulted in North Creek commercial manufacturing approval.-MFG representative on change review board which provide change control design guidance and overall endorsement of site level change controls.-Assist with company wide directive.

Bothell, Washington, US

-Assisted in the transition of Quality Management Systems serving as point of contact for workflow questions. -Authored several risk assessments in response to material supply constraints (related to global pandemic) in order to ensure continued operations.-Implemented a collaborative working space for deviation investigations.-Provided quality system.

Bothell, WA, US

• Supervises teams (3-6 in size) in the successful execution of downstream production processes for GMP manufacturing operations.
• Oversees the qualification, training and development of staff members via goal setting, assignment of development activities, performance reviews, etc.
• Manages the completion of required documentation including but not limited to deviation reports, change control, product change over and maintenance task.
• Organizes the daily work flow, delegating responsibilities for shift operations as needed.

Bothell, WA, US

• One of team leads for process operations including High-performance liquid chromatography (HPLC), UFDF operations, and other downstream process ops.
• Worked with multiple departments and clients to investigate and write-up of a critical deviations.
• Investigated numerous deviations and assisting with keeping the metrics low.
• Served as one of founding mentors of the high school internship program, teaching individuals the basics of aseptic technique, Good Manufacturing Practice and process operations. Note: all individuals trained were.
• Collaborated and authored multiple standard operations procedures (SOPs).
• Traveled to sister-site location in Berkeley, CA to assist with new mid-scale project molecule in all aspects downstream.

Bothell, WA, US

• Purification
• Promoted from a Manufacturing Support Technician III.
• Selected as primary operator to perform in-front of FDA inspector during 2018 FDA biennial inspection.
• Identified as a key leader to help lead successful PPQ Campaigns.
• Downstream Representative for Environmental Monitoring Excursion Team.
• MasterControl: Lead Author of SOP changes and initiation, CAPA generation and implementation, deviation investigations.

Bothell, WA, US

• Promoted from a Manufacturing Support Technician II in recognition of commitment to compliance, quality, work ethic and overall excellence.
• Served as acting supervisor to coordinate inter-department collaborate and overall product success, when needed.
• Proficient working in ISO 7 and 8 clean rooms as well as GMP laboratory.
• Member of CMC's sustainability team 'Green Team' which focuses on optimizing waste reduction generated by manufacturing process.
• Crossed trained in both the Warehouse and Cell Culture departments to assist with over flow work items such as harvest and raw materials dispensing.
• Trained on aerial lift (WAV and lift pod) as well as forklift certified.

Bothell, WA, US

• Lead support unit operations:
• Certified Trainer for the Laboratory Information Management System (L.I.M.S).
• Crossed trained in both the Warehouse and Cell Culture departments to assist with over flow work items such as harvest and raw materials dispensing.
• Calibration of volumetric glass equipment.
• Participated in initiation, investigation and closure of deviation reporting.
• Preparation of media and buffers.

Redlands, CA, US

• Identified problems in machine operation and generated an action plan that resulted in 10% increase product uniformity.
• Oversaw the production quality of multiple departments by ensuring operators strictly adhered to both Operator Work Instructions (O.W.I.’s) and Manufacturing Orders (M.O.’s), approving or rejecting materials based on.
• Performed basic chemical analysis (percentage of free lead or lead oxide, specific gravity checks, moisture content, etc.) to determine compliance.
• Documented first article inspection results by inputting data into database and generated summary reports for Quality Manager and Director of Engineering & Quality.
• Conducted various trainings on quality expectations in both English and Spanish.
• Familiar with AS9100 C and ISO 9001:2008 quality standards.

Redlands, CA, US

• Entrusted to lead production line and write production documentation.
• Performed battery packaging preparations.
• Ensured that the final appearance and quality of battery packaging is of the highest standard.

Redlands, CA, US

• Labelled battery cases and boxes to display environmental and safety regulations.
• Prepared necessary material for packaging of batteries.
• Scanned batteries into an Access database to ensure orders were complete.
• Kept work station clean and safe.

Tutored multiple students from middle to high school in mathematics and science. Wrote individualized monthly progress reports based on the each student's level of understanding of class material. Once students demonstrated subject mastery, I provided real world examples and challenges based on their current curriculum to motivate students to take an.

• Obtained a San Bernardino County Food Handlers Card
• Respond and resolve customer’s requests and concerns
• Collaborate with other team members to complete orders in a timely manner to satisfy customers' requests

• Proven ability to operate cash register and manage drawer
• Demonstrated ability to respond and resolve customer’s requests and concerns
• Assist customers with purchases and transactions
• Experienced in restocking merchandise
• Meticulous competency in sales, products and services
• Enforced CA restricted items sales laws

Stockton, California, US

Supervised, trained and coached Library Student Assistants to manage the Circulation Desk when permanent staff members need break or are unable to work. Worked on special projects for the library such as processing new material and cataloging. Primary responsible for resolving patron disputes and up keeping library facilities and all its operations i.e..

Stockton, California, US

Collaborated with Housing and Greek Life staff to provide a cultivating work environment for Resident Assistants that allows them to perform their job responsibilities effectively and efficiently while also develop professionally. Oversaw Hall Government by encouraging officers to work cohesively and make community conscience decisions and guided meeting.

Stockton, California, US

Provided quality customer service to patrons by portraying positive attitude, being knowledgeable of all library policies and procedures and willing to find and explain all possible alternatives to an issue. Managed all library material and equipment so that work efficiency is continued as well as handled the integrated Aleph Library computer system to.

Stockton, California, US

First responder to residents’ issues ranging from concerns of personal safety or health to improvement of living provisions. Created a safe and unifying residence for individuals by organizing various programs that stressed the importance of personal development and growth.

Santa Clara, CA, US

Primary responsibility was running benchmark tests on commercial and developmental GPUs for both the engineering and marketing teams. Presented this data in concise yet descriptive reports and excel documents for technical and non-technical personnel including company Vice Presidents. Advised lab manager on financial decisions affecting both the Santa.