Mark Langemach Email & Phone Number

Greenfield, In, Us

After the purchase of KindredBio by Elanco in 2021, staff were rolled over into Elanco and titles were standardized based on Elanco's systems. New role continued previous responsibilities while standardizing expectations with Global Elanco Standards. • Led team to validate assays for USDA release of commercial biologics. • Helped site achieve first product licensure for Canine Parvovirus Monoclonal Antibody. • Assisted in preparing for and participation in site licensing which culminated in a USDA licensing audit. • Participate in Annual Outline Reviews for regulated documentation and methods. • Coordinate with cross-functional teams of experts to achieve priority goals within important timelines. • Participate in critical editing and review of information being submitted to the USDA. • Developed a site-stability program to meet regulatory and company global standards. • Authored site retention program for government-regulated samples as well as pulling samples as needed. • Regularly display analytical space to site visitors, including executive staff and regulatory officials.• Utilize SAP systems for regular PO generation and material ordering.• Generated robust training programs for employees to gain useful knowledge for regular activities. • Coach employees on development plans while attempting to provide opportunities for advancement. • Constantly foster an inclusive environment and provide beneficial feedback to train and retain staff. • Practice responsibly delegating tasks to team to ensure proper workload for self and others.

• Manage a larger team of quality employees to accomplish timeline critical tasks.• Assist regulatory in making changes to the Outline of Production and addressing CVB comments.• Shepherd assay validations to completion, including the routing of Special Outlines to CVB. • Focus employees on company and personal goals for year-end reviews and provide honest and helpful feedback as needed. Thoughtfully incorporate successes and concerns into pay-affecting evaluations. • Manage finances of QC department including expense reports, PO reconciliation, and budgeting. • Perform all responsibilities of both QC Group Leader and QC Analyst.

Responsible for managment of quality control (analytical) testing of clinical and commercial supplies for on-site manufacturing.• Schedule/Manage routine and non-routine analysis of in-process materials, raw materials, environmental samples, finished goods, or stability samples.• Ensure the quality control lab is held to GxP standards and safety standards.• Support testing in the laboratory per specification and method requirements.• Perform regular ordering of lab materials along with PO creation and tracking of equipment calibration and preventative maintenance. Prepare budgeting documentation. • Deal with contract laboratories and act as the point person between companies. • Review OOS/OOT investigations and review deviations related to Quality Control.• Review data to ensure accuracy and regulatory compliance. • Manage the training of other analysts to perform laboratory procedures and assays. • Manage Equipment validation, calibration, maintenance, and troubleshooting for QC labs. • Serve as the quality control subject matter expert during cross-functional/project meetings. • Review method validation protocols/reports and other documentation such as analytical reports.• Create or review stability protocols and stability reports and manage the stability program for GMP samples.• Review and approve standard quality control operations procedures.• Maintain a working knowledge of cGMP, 21 CFR, 9 CFR, USP, ICH and other related regulations and guidance to ensure company compliance.

• Created methods from start to finish including assay development, method writing, validation, and review. These methods are then used for regular QC testing. • Acted as an expert and train other employees on different assays including plate ELISA, cIEF, CE-SDS, CD-ELISA, SEC-HPLC, Osmolality, pH, SDS-PAGE, Western Blot, and Appearance testing. • Successfully participated in product release testing. • Cross trained with Microbiology to perform EM testing for manufacturing suite.

Minneapolis, Mn, Us

Prepare environmental samples including water, soil, and assorted waste for analysis for different harmful substances such as metals, PCBs, etc. Acted as the supervisor of 7 employees. • Use the internal LIMS to properly keep track of samples being used or disposed. • Run daily reports to understand the workload in our queue and batch out work for coworkers and myself. • Perform extractions of samples according to SOPs with urgency to meet strict deadlines. • Maintain machinery including calibrations, cleaning, and repair. • Properly handle, mix, and store chemicals necessary for testing. • Participate in LEAN daily management, Kaizan events, and other organizational activities to promote efficiency in our lab.

Maryville, Mo, Us

Gave prospective students complete tours of campus. Served on student panel for large group visit days and answered any questions students or parents had regarding the University. Remained up to date on current university policies and procedures as well as specific departmental details.

Maryville, Mo, Us

Used technology training to help students and faculty with personal and university equipment. Remained familiar and comfortable with all current Microsoft Office programs and general technology needs. Provided superb customer service and remained approachable to everyone. Did general repair work for hardware and some software issues.

Atlanta, Ga, Us

Served as a front of house and occasional kitchen employee.Duties included providing superior customer service, sale and knowledge of products including catering options, general cleaning and maintenance of store, leadership and some training of younger/newer employees, money handling such as balancing drawers at close. Worked August 2011-June 2012 and then seasonally when home from college until 2015.Earned a raise within the first three months of starting.

Irving, Tx, Us

Spent a total of five summers working on the Camp Geiger Staff and served in three different positions. 2009- Served in the Camp Store. Duties included providing customer service, sale of merchandise, and general cleaning and maintenance of store and facilities surrounding the building.2010,2012-2013- Served on the Nature Staff. Duties included instructing scouts in nature related merit badges (Environmental Science, Space Exploration, Reptile and Amphibian Study, etc), assisting other staff members with nature hikes or similar outings, and general cleaning and maintenance of Nature Lodge. 2011- Instructed scouts how to mountain board around camp. Duties included instructing scouts on proper safety procedures and techniques and demonstrating these skills, instructing scouts and performing routine maintenance on equipment, an administering first aid for any injuries that occurred. General duties while in this position were to create a fun and energetic environment for all scouts attending the camp, encourage safety during emergencies, and be the general leadership of the camp.