AI/ML Data Scientist Jobs in Holdrege, Nebraska

High salary

Site Validation Engineer

Katalyst HealthCares & Life Sciences Holdrege, NE

Location: Lake County, IL (Hybrid (4 days onsite)) Duration: 12-months Top Skills and Education Required for the Role Bachelor’s Degree, or equivalent education, with typically 7 or more years’ experience or master’s degree or equivalent education with 3 years’ experience in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar area. (PhD with 0+ years' experience acceptable). Supporting the process development of parenteral drug products with a focus on antibody drug conjugates (ADCs). Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), to develop robust dosage forms. Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments. Demonstrated scientific writing skills and strong verbal communication skills. Job Description Product Development Science and Technology (PDS&T) is seeking a motivated Scientist to support parenteral drug product process development, scale-up, and technology transfer to commercial manufacturing sites. This role will focus on the development of robust manufacturing processes for clinical and commercial-phase products, with an emphasis on antibody-drug conjugates (ADCs). The Scientist will independently design and execute laboratory studies, generate and analyze precise and reproducible data, and contribute to cross-functional product development and Chemistry, Manufacturing, and Controls (CMC) teams. Responsibilities Design and execute studies to develop and optimize manufacturing processes for parenteral drug products. Conduct stability assessments of biologics by evaluating their chemical and physical properties under various conditions, including pH, ionic strength, temperature, light, and moisture exposure. Assess the impact of manufacturing process stresses (e.g., freeze-thaw cycles, mixing, filtration, filling, and lyophilization) on product stability and performance. Interpret experimental results, identify significant deviations, and propose and execute follow-up studies to refine process parameters. Support scale-up activities and technology transfer to commercial manufacturing sites. Prepare technical reports, regulatory documentation, and presentations to communicate findings effectively. Requirements Bachelor’s degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with 7+ years of relevant experience, OR Master’s degree with 3+ years of experience, OR PhD with 0+ years of experience. Strong background in parenteral drug product development, particularly ADCs. Experience with formulation stability studies and analytical techniques for biologics. Demonstrated ability to analyze data, troubleshoot experiments, and optimize processes. Excellent scientific writing and verbal communication skills. Seniority Level Mid-Senior level Employment Type Full-time Industries Pharmaceutical Manufacturing #J-18808-Ljbffr

AI/ML Data Scientist jobs in Holdrege