Methods Specialist

MSD Malaysia; De Soto (KS); Hybrid; USD 79,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation time

Sick days

Job summary

Merck Animal Health in the United States seeks a Methods Specialist to support biomaterials management, method remediation, and regulatory documentation for USDA-regulated biologics. This role ensures inventory, documentation, and collaboration with QA, Regulatory Affairs, R&D, and external suppliers.

The position requires a Bachelor’s in biological sciences and at least 5 years of experience with USDA-regulated biologics, with expertise in immunoassays or cell-based methods and strong technical

Qualifications

• Bachelor’s degree in biological sciences or closely related field.
• Minimum 5 years’ experience with USDA-regulated animal health biologics.
• Strong scientific writing and documentation skills.

Responsibilities

• Maintain biomaterials documentation and production history.
• Monitor biomaterials inventory and expiry risks.
• Support biomaterials replacement planning and equivalence qualification.
• Assist with method remediation when biomaterials affect performance.
• Support transfer to QC laboratories.
• Draft technical reports and regulatory support documents.
• Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers.

Skills

Biomaterials management

Regulatory documentation

USDA-regulated biologics

Immunoassays

Cell-based methods

Technical writing

Cross-functional collaboration

Regulatory submissions

Education

Bachelor’s degree in biological sciences

Job description

Job Description Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills) 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.

Methods Specialist The Methods Specialist supports biomaterials management and method remediation activities for USDA-regulated animal health biologics. This role helps maintain biomaterials documentation, monitor inventory, support replacement and equivalence qualification activities, assist with QC transfer, and prepare technical documentation for regulatory review.

Key Responsibilities

• Maintain biomaterials documentation, including production history, characterization, inventory status, qualification status, and method dependencies.
• Monitor biomaterials inventory, usage trends, expiry risks, and reorder triggers.
• Support biomaterials replacement planning, sourcing evaluations, and equivalence qualification activities.
• Assist with method remediation when biomaterials impact biological method performance.
• Support transfer of biomaterials and remediated methods to QC laboratories.
• Draft or contribute to technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA or CVB review.
• Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, Supply Chain, and external suppliers.

Minimum Qualifications

Bachelor’s degree in a biological science, such as Biology, Microbiology, Genetics, Virology, or a closely related discipline. Minimum of 5 years of experience in USDA-regulated animal health biologics, veterinary biologics. Developing subject matter expertise in at least one biological method platform, such as immunoassays, cell-based methods, or other relevant biological test systems. Strong scientific documentation and technical writing skills.

Preferred Qualifications

Experience qualifying biomaterials or preparing biomaterials-related technical documentation for regulatory review. Experience working with CVB or supporting USDA-regulated veterinary biologics submissions. Experience with regulated quality systems, method validation, method transfer, or method remediation. Experience collaborating across multiple departments or external organizations.

Required Skills

• Adaptability
• Adaptability
• Analytical Method Transfer
• Biocompatibility
• Biologics
• Biology
• Biomaterials
• Bioproduction
• Bioproducts
• Bulk Load
• Cell Separation
• cGMP Compliance
• Column Chromatography
• Computer Literacy
• Contract Manufacturing
• Data Analysis
• Environmental Health and Safety (EHS) Management
• Equipment Set Up
• External Manufacturing
• Immunoassays
• Lean Manufacturing Tools
• Method Development
• Method Validation
• Microbiology
• Process Monitoring {+ 10 more}

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.

The salary range for this role is $79,200.00 - $124,700.00 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.

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.

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: 10/9/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.