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.
• 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.

• 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.

• 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.

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.

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.