Specialist, Lyophilization Cycle Optimization

Job Description

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.

Key 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.

Minimum qualifications

• 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.

Experience & skills

• 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.

Preferred qualifications

• 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.

 

What We’re Looking For

We seek individuals who:

• Demonstrate execution excellence through effective problem-solving and critical thinking.

• Embrace an entrepreneurial mindset, taking initiative and ownership of their work.

• Adapt with agility and resilience in a dynamic, fast-paced environment.

• Uphold a safety-first mindset, ensuring the well-being of themselves and their colleagues.

Why Join Us?

• Be part of a transformative investment that will shape the future of animal health.

• Work in a region renowned for its skilled workforce, strategic location, and robust infrastructure.

• Contribute to cutting-edge research and manufacturing of large-molecule vaccines and biologic products.

Help us meet growing global demand for our portfolio of animal health solutions

#GAHM-ILC

Required Skills:

Adaptability, 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 {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$87,300.00 - $137,400.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/4/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.