Methods Specialist

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

Job summary

HireLifeScience is seeking a Methods Specialist to support biomaterials management and method remediation for USDA-regulated biologics. You will maintain documentation, monitor inventory, and assist with regulatory review.

The role requires a biology background, 5+ years in regulated biologics, and strong technical writing skills. Hybrid work and competitive benefits are offered.

Qualifications

• Bachelor's degree in a biological science is required.
• Minimum 5 years of experience in USDA-regulated animal health biologics.
• Developing subject matter expertise in at least one biological method platform.
• Strong scientific documentation and technical writing skills.

Responsibilities

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

Skills

Adaptability

Analytical Method Transfer

Biocompatibility

Biologics

Biology

Biomaterials

Bioproduction

Bioproducts

Column Chromatography

cGMP Compliance

Data Analysis

Immunoassays

Method Development

Method Validation

Microbiology

Process Monitoring

Lean Manufacturing Tools

Equipment Setup

External Manufacturing

Contract Manufacturing

Environmental Health and Safety

Computer Literacy

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}

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.

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.

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 .

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

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

*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.

Requisition ID

R419136