Mike Kvernevig

*** ******** ***

Charles City, IA 50616

Cell: 641-***-****

Email: acs4vu@r.postjobfree.com

QUALIFICATIONS

Over 12 years of experience as a production supervisor for a medical device manufacturing company.

Over 5 1/2 years experience in the veterinary pharmaceutical/biotechnology industry and the medical device industry. Specialized in the areas of product development (improvement), vaccine production, equipment and process validation. Over 5 1/2 years of experience in validation in writing IQ, OQ and PQ protocols, executing protocols, performing calibration on equipment and writing up summary reports. Experience also includes writing SOPs, knowledge of cGMPs, USP and Federal Standards. Over 1 years of experience in HEPA filter and clean room certification, this included environmental monitoring.

WORK EXPERIENCE

Cambrex, Inc (API Pharmaceutical Co)

Charles City, IA (Sept. 2014 – Sept 2015)

Cambrex is a pharmaceutical company specializing in Contract Custom Manufacturing and Development of APIs and other small molecule therapeutics.

Worked as a Production Supervisor in the Pilot Plant area of the company which also included the Kilo Lab (small scale) and HIPO areas. Supervised daily activities of 12 employees whose jobs were to operate small scale equipment in order to validate new customer products for process scale up and process optimization as well as to produce HIPO (High Potency) products such as fentanyl. Responsibilities also included making sure employees worked in a safe environment and in a safe manner while following all of the Company safety policies. Trained in wearing respirators such as SCBA and PAPR type respirators. Also trained confined space rescue and HAZWOPER 40 hr course. Worked with controlled substances. Duties also included reviewing Log books, doing internal audits and housekeeping audits of paperwork and work centers respectively. Duties also included reviewing batch records for completion, scheduling of personnel on their daily activities, doing safety reviews and troubleshooting of certain process and equipment issues.

ThermoFisher Scientific, Remel Inc. (Medical Device Manufacturing Company)

Lenexa, KS (July 1999 – June 2014)

Remel, a line of products owned by Thermo Fisher Scientific, is a medical device company specializing in the manufacturing and sale of class I and class II medical devices that are for in-vitro or research/clinical use only. This includes products (media, reagents, stains, etc.) used for culturing microorganisms, microbial isolation; microbial transportation, microbial identification, microbial verification, environmental monitoring, etc. just to name a few.

Production Supervisor (Supervisor Tubes/Bottles Dispensing/Packaging Dec. 02 – June 14)

Serving as a production supervisor overseeing daily production schedule and administration duties. Responsibilities include, but are not limited to, being available for decisions that effect product quality, making decisions that effect amount of products dispensed and their quality. Oversaw 30+ employees whose jobs range from dispensing, aseptic dispensing, clean-room production, media preparation, pH’ing, thermal processing and product labeling and packaging. Responsibilities also include administration duties such as employee counselings, delegating work loads, enforcing company policies, schedule employee time off, change SOPs, DHRs as appropriate, performance reviews, JSAs, QSR compliance (cGMP) and making sure employees follow safety and production SOPs. A member of the PERT team that monitors and corrects problems associated with products failing due to performance. Meeting specified goals of low WIP discards, low IDFs, low customer complaints and increase productivity by monitoring production, back orders and inventory levels and help meet customer requirements (quality) and demands. Trained in Lean Manufacturing (lean production) and using such tools as Kanban system, Heijunka Scheduling, 5S, Value Streams, PPI and Kaizens to name a few to help eliminate waste and improve quality while at the same time decrease production time and cost. Also responsible for labor planning, improving product availability (eliminate backorders) and improving production output/uplh.

Validation (Validation Specialist July, 99 – Dec. 02)

Responsibilities included, but were not limited to the modernizing (updating) of the current Validation of all equipment and processes that are used by Remel production. This included writing protocols, executing protocols, writing summary reports, performing calibrations on RTDs, thermocouples, Validator 2000, pressure gauges, pressure transducers, etc., writing and updating SOPs and helping to establish a database for tracking validation schedules and completed validations. Responsibilities also include helping to verify company is following QSR and to help improve product quality through improving production processes.

Systems validated included R/O water system, steam system, Super-Q water System, Aseptic and non-aseptic filling machines, Autoclaves, Label machines, Kettles, Lyophilizers, HSHTs, Inspissator and Building Utilities.

Raytheon Engineers & Constructors (Validation Contract Group)

Kansas City, MO (May 1997-July 1999)

Fort Dodge Animal Health

Fort Dodge, IA (January, 91 – September, 96)

Bioreactors: (Bio-Lab Technician, January, 1991 - September 1995)

Cleaned, sterilized and operated both small and large volume (30L-1,000L) bioreactors for the production of viral stocks used in the manufacturing of vaccine products. Worked with Honeywell UDC-9000 and UDC-3000 (watchdogs) controllers and chart recorders used to monitor and control bioreactor parameters. Helped perform regular, semi-annual and annual preventive maintenance and troubleshooting of all bioreactors. Helped scale up (grow) clean tissue cultures, using both roller bottles and cell cubes, for use in viral antigen production. Trained in and proficiently uses aseptic techniques; safe handling, use and discarding of hazardous biological and chemical agents (substances). Performed viable and non viable (total) cell counts, inactivated viral stocks, calculated amount of seed needed for infection using MOI and titer. Kept records of such tasks and others performed during the entire production process according to cGMP and cGLP regulations. Supervised 6 workers during bioreactor run, (pressure hold, sterilization, plant, infect, harvest, kill and DSP), and aided in troubleshooting any problems encountered. Utilization of ‘Membrex’ filtration process equipment. Responsible for the environmental monitoring of bioreactor suites (clean rooms) and aseptic corridors using a particle counter, RODAC plates and a slit air to agar air sampler. Plates were incubated and checked for growth every day. After the incubation period, colonies (if present) were counted and identified. Data of particles found in the rooms were read to determine if the rooms met CFR (209E) standards. Helped write Departmental SOPs and M.D.s. (manufacturing directions). Aided in the Validation of Bioreactors and Fermentors by performing OQs and PQs. Validation included, but was not limited to, helping execute thermal mapping (heat distribution and penetration) studies on bioreactors, fermentors and a few autoclaves using biological indicators and thermocouples. PQs required using TSB as a medium in a mock run to validate the sterilization and integrity of the vessel.

Fermentors: (Product Development; December, 1995 - September, 1996)

Cleaned, sterilized and operated both small and large volume (15L-250L) fermentors for the production of bacterin lots used in the optimization studies of vaccine products. Controllers include Allen-Bradley (Touchscreen) & Braun. Helped perform regular and semi-annual preventive maintenance and troubleshooting of all fermentors. Performed OQ and PQ protocols on a 250-Liter fermentor. Performed bacterial identification, bacterial and tissue culturing, mammalian cell and bacterial counts, and culturing viral and bacterial microorganisms on a large and small-scale volume. Performed optimization studies on new and existing products to create cheaper, safer and more effective antigens. Initiated and implemented new methods for the improvement of existing products. Worked with RND personnel in developing and testing new product lines. Followed FDA cGLPs while working with licensed and unlicensed antigens. Pathogens where handled and discard in a safe and FDA approved manner.

EDUCATION and CREDENTIALS

National Career Readiness Certificate – Gold Level (November 2015)

*Reading for Information – Platinum, *Applied Math – Platinum, *Looking for Information - Gold

B.S. degree / Microbiology

South Dakota State University

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