Associate Scientist

Associate ScientistFull Time ProfessionalKANSAS, Wamego, KS, US

Axiota Animal Health is an innovative global company that discovers, develops, and markets products for beef and dairy producers consistent with market and consumer demands. Axiota’s focus is to deliver superior, first-in-class products that are scientifically proven with known modes of action, provide measurable commercial efficacy, and are accepted by consumers.

What We Manufacture and SellAxiota’s non-antibiotic solutions prepare cattle to thrive during transition and stress and support producers’ goals of optimal health, performance, and animal well-being. Axiota’s field-based sales and technical teams support beef and dairy producers and their technical advisors. Our current cattle product platform includes Multimin® 90, an injectable trace mineral used for strategic supplementation of cattle, and Lactipro®, a rumen native probiotic that promotes healthy rumen function and stabilizes pH. Axiota plans to expand both platforms to additional species and applications in the future. Axiota develops our innovative solutions through two technology centers – the MS Biotec® Microbial Technology Center and the Warburton Injectable Trace Mineral Technology Center.The MS Biotec microbial technology center is located in Wamego, Kansas which is our production, R&D and logistics center for Lactipro products.

Responsibilities:Manage study protocols and study conduct, intimately involved in the toxicology and pharmacokinetic study protocol development process.Generate crispr knockout STAT1, STAT3 and STAT1 & 3 double knockout cell lines.Use CRISPR technology to create target knockout cell line.Direct ISO 9000 4.10 team registration activities and perform internal audits.Prepare stock reagents and buffers for use in manufacturing assay kits.Confirm the quality of product meets specifications according to cGMP and ICH guidelines.Complete all relevant paperwork according to specific ISO regulations and guidelines for IVD.Perform TaqMan assays to validate the assay & optimize assays to be implemented in HTS.Develop and qualify ADA and PK/TK assays for non-clinical and clinical studies utilizing MSD and ELISA platforms.Review in-house and customer's method-validation protocols and reports to ensure adherence to USP and ICH guidelines.Cloned and amplify DNA fragments generate both sense and anti-sense RNA probes.Perform RNA isolation, RT-PCR, PCR, and sequencing of top clones for projects as a quality control check.Develop LC-MS methods to analyze and synthesize small molecules, conjugate dyes and conjugate linkers (to protein and polymers).Provide manufacturing support to produce ELISA components.Perform toxicity risk assessment to support QC investigations.Perform general wet chemistry analysis including pH, viscosity, specific gravity, and percent solid.Develop and validate HPLC assays for quantification complex fermentation matrix.Perform calibration, verification, preventive maintenance, and performance qualification on HPLC systems, and dissolution apparatus.Investigate the formation of impurities in the manufacturing of oligonucleotides using SAX-HPLC.Optimize differential scanning calorimetry (DSC) method to identify glass transition temperature for lyophilize formulations.

Skills/Qualifications:Bachelor's degree in Chemistry, Biochemistry, Biology, Microbiology, etc. or equivalent and relevant formal academic/ vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6 + years). At least one year of GMP experience in a regulated lab is required.Strong experience with Stability Samples and Stability Protocols is required.Must demonstrate good communication skills, particularly in documentation of data.The candidate must be able to work in a team environment and deliver when working under assigned timelines and with minimal supervision.Understanding of cGMP and Environmental Health and Safety requirements is essential. Ability to follow all applicable SOPs, internal requirements and external regulations is a must.Expertise in MS Office applications, in particular MS Word and Excel, is required. Familiarity with electronic documentation systems (e.g., QUMAS, Infinity, LIMS) for routing protocols/reports, for review and approval is a plus.Familiarity with common pharmaceutical laboratory test methods and technical writing is desired.

Physical Requirements:Capable of communicating, receiving, and comprehending information and ideas from diverse groups of people clearly and logically. Work while standing upright or stationary for the duration of typical working hours, lift and move objects weighing up to 50 pounds. Capable of working in non-traditional work environments, possess proficiency in using and learning standard office equipment and technology. You may be exposed to potentially hazardous elements, such as infectious agents often found in Biotech or laboratory environments and perform successfully under pressure while prioritizing and handling multiple projects or activities.

Compensation and Benefits:Axiota offers a competitive base salary plus bonus and benefits, which include medical, dental, vision, life insurance, 401K retirement plan w/match FSA, HSA, EAP, short-term and long-term disability, paid time off, and nine paid holidays.

Axiota is an Equal Opportunity Employer. We strive to foster a culture of respect and seek to empower each individual. All employment decisions are based on merit, qualifications, experience, and abilities. This employer uses E-Verify.