Specialist, Lyophilization Cycle Optimization

Merck•De Soto, KS

1d•Hybrid

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Join Us in Shaping the Future of Animal Health. Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s second largest economic development project to date. As a Specialist, Lyophilization Cycle Optimization, you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally. You will support the start-up and continuing operations of a new manufacturing facility by ensuring optimal lyophilization (freeze-drying) cycles.

Requirements

BS in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemistry, or related discipline plus two (2)+ years of hands-on laboratory experience; internships, co-ops, or academic research involving freeze-drying, protein formulation, or pharmaceutical process development are acceptable OR MS in Chemical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemistry, or related discipline.
Familiarity with thermal analysis techniques (DSC, freeze-dry microscopy) and moisture analysis (Karl Fischer) through coursework, lab rotations, or practical experience.
Basic understanding of freeze-drying principles and heat/mass transfer concepts.
High degree of ownership, scientific rigor, and continuous improvement mindset.
Strong attention to detail, good problem-solving skills, and ability to follow experimental protocols.
Effective written and verbal communication skills and ability to work collaboratively in cross-functional teams.
Adaptability
Change Control Management
Chemical Engineering
Data Analysis
Disease Prevention
Equipment Troubleshooting
Freeze Drying
Good Manufacturing Practices (GMP)
Lean Manufacturing
Moisture Analysis
Oral Communications
Personal Initiative
Pharmaceutical Sciences
Process Engineering
Process Optimization
Process Technologies
Process Validation
Professional Integrity
Project Management
Root Cause Analysis (RCA)
Routine Maintenance
Technical Writing
Technology Transfer
Vaccine Manufacturing

Nice To Haves

Internship or co-op experience specifically involving lyophilization or biopharmaceutical formulation.
Experience with electronic lab notebooks, LIMS, or basic process modeling tools.
Interest in technology transfer and manufacturing process scale-up.
Demonstrated initiative through undergraduate research projects, senior design, or relevant publications/posters.

Responsibilities

Design and execute laboratory-scale lyophilization experiments to develop and optimize freeze-drying cycles (freezing, primary drying, secondary drying) under supervision.
Characterize formulation thermal and physical properties (e.g., collapse temperature, Tg’) using DSC and freeze-dry microscopy.
Measure quality attributes using loss on drying, Karl Fischer, and other techniques.
Support evaluation of formulation excipients and container-closure systems for lyophilization compatibility and stability.
Monitor and record in-process parameters (e.g. shelf temperature, chamber pressure, product temperature etc) and assist in correlating these with product quality attributes.
Help define critical process parameters (CPPs) and critical quality attributes (CQAs) under guidance from senior staff.
Contribute to development of scale-up strategies and scale-down models, addressing basic heat and mass transfer considerations for transfer to commercial lyophilizers.
Perform calculations and contribute to determination of vial heat transfer coefficients (Kv) and product resistance (Rp) values.
Support technology transfer activities by preparing experimental records, draft batch records, and SOPs; assist in training of pilot/manufacturing teams.
Participate in process validation and qualification studies with commercial manufacturing equipment.
Maintain accurate lab notebooks and electronic records in compliance with company quality systems.
Collaborate with formulation scientists, analytical development, process engineering, manufacturing, QA, and regulatory teams.
Perform routine maintenance and support qualification/calibration activities for laboratory lyophilizers.